A Phase 3 interventional study of ABT-450/r/ABT-267 and ABT-333 in Chronic Hepatitis C Virus (HCV) Infection Genotype 1, sponsored by AbbVie. Completed at 187 sites in 27 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.
950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.
This study's enrollment of 1,596 is above the median of 90 across 696 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
Drug: ABT-450/r/ABT-267 · Drug: ABT-333 · Drug: Ribavirin (RBV)
Drug pages: Paritaprevir · Ritonavir · Ombitasvir
Tablet for oral use
Also known as: ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, Paritaprevir/ritonavir/ombitasvir also known as Viekirax
Tablet for oral use
Also known as: ABT-333 also known as dasabuvir, ABT-333 also known as Exviera
Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing \< 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
All-Cause Death: Time to Event
Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
Time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
Liver-Related Death: Time to Event
Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
Time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
Liver Decompensation: Time to Event
Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
Time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
Liver Transplantation: Time to Event
Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
Time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
Hepatocellular Carcinoma: Time to Event
Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
Time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.
Time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
Change From Baseline in FibroScan Score by SVR12 Status
The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.
Time frame: At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.
Time frame: 12 weeks after the last actual dose of study drug
| Milestone | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| Started | 1596 |
| Completed | 1258 |
| Not completed | 338 |
| Withdrew: Adverse event | 24 |
| Withdrew: Withdrew consent | 96 |
| Withdrew: Lost to follow-up | 126 |
| Withdrew: Covid-19 infection | 2 |
| Withdrew: Covid-19 logistical restrictions | 33 |
| Withdrew: Other, not specified | 57 |
Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
| percentage of participants | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
|---|---|---|
| Kaplan-Meier estimate at PT Week 52 | 8.3 (3.1 to 21.2) | 0.1 (0.1 to 0.4) |
| Kaplan-Meier estimate at PT Week 104 | 8.3 (3.1 to 21.2) | 0.7 (0.4 to 1.1) |
| Kaplan-Meier estimate at PT Week 156 | 8.3 (3.1 to 21.2) | 1.2 (0.8 to 1.8) |
| Kaplan-Meier estimate at PT Week 208 | 8.3 (3.1 to 21.2) | 1.5 (1.1 to 2.2) |
| Kaplan-Meier estimate at PT Week 260 | 8.3 (3.1 to 21.2) | 2.0 (1.5 to 2.8) |
Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
| percentage of participants | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
|---|---|---|
| Kaplan-Meier estimate at PT Week 52 | 1.4 (0.2 to 9.6) | 0 (NA to NA) |
| Kaplan-Meier estimate at PT Week 104 | 1.4 (0.2 to 9.6) | 0 (NA to NA) |
| Kaplan-Meier estimate at PT Week 156 | 1.4 (0.2 to 9.6) | 0.1 (0.1 to 0.4) |
| Kaplan-Meier estimate at PT Week 208 | 1.4 (0.2 to 9.6) | 0.1 (0.1 to 0.4) |
| Kaplan-Meier estimate at PT Week 260 | 1.4 (0.2 to 9.6) | 0.1 (0.1 to 0.4) |
Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
| percentage of participants | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
|---|---|---|
| Kaplan-Meier estimate at PT Week 52 | 4.5 (1.5 to 13.4) | 0.2 (0.1 to 0.5) |
| Kaplan-Meier estimate at PT Week 104 | 4.5 (1.5 to 13.4) | 0.2 (0.1 to 0.5) |
| Kaplan-Meier estimate at PT Week 156 | 4.5 (1.5 to 13.4) | 0.3 (0.1 to 0.6) |
| Kaplan-Meier estimate at PT Week 208 | 4.5 (1.5 to 13.4) | 0.3 (0.2 to 0.7) |
| Kaplan-Meier estimate at PT Week 260 | 4.5 (1.5 to 13.4) | 0.5 (0.2 to 0.9) |
Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
| percentage of participants | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
|---|---|---|
| Kaplan-Meier estimate at PT Week 52 | 0 (NA to NA) | 0 (NA to NA) |
| Kaplan-Meier estimate at PT Week 104 | 0 (NA to NA) | 0 (NA to NA) |
| Kaplan-Meier estimate at PT Week 156 | 0 (NA to NA) | 0.1 (0.1 to 0.4) |
| Kaplan-Meier estimate at PT Week 208 | 0 (NA to NA) | 0.1 (0.1 to 0.4) |
| Kaplan-Meier estimate at PT Week 260 | 0 (NA to NA) | 0.2 (0.1 to 0.5) |
Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
| percentage of participants | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
|---|---|---|
| Kaplan-Meier estimate at PT Week 52 | 0 (NA to NA) | 0.2 (0.1 to 0.5) |
| Kaplan-Meier estimate at PT Week 104 | 0 (NA to NA) | 0.4 (0.2 to 0.8) |
| Kaplan-Meier estimate at PT Week 156 | 0 (NA to NA) | 0.5 (0.3 to 1.0) |
| Kaplan-Meier estimate at PT Week 208 | 0 (NA to NA) | 0.6 (0.4 to 1.1) |
| Kaplan-Meier estimate at PT Week 260 | 0 (NA to NA) | 0.9 (0.5 to 1.4) |
Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.
| percentage of participants | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 |
|---|---|---|
| Kaplan-Meier estimate at PT Week 52 | 11.4 (5.2 to 24.2) | 0.5 (0.3 to 0.9) |
| Kaplan-Meier estimate at PT Week 104 | 11.4 (5.2 to 24.2) | 1.2 (0.8 to 1.8) |
| Kaplan-Meier estimate at PT Week 156 | 11.4 (5.2 to 24.2) | 1.9 (1.4 to 2.6) |
| Kaplan-Meier estimate at PT Week 208 | 11.4 (5.2 to 24.2) | 2.3 (1.7 to 3.1) |
| Kaplan-Meier estimate at PT Week 260 | 11.4 (5.2 to 24.2) | 3.2 (2.5 to 4.1) |
The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.
| kPa | Participants in Study M14-423 Who Did Not Achieve SVR12 | Participants in Study M14-423 Who Achieved SVR12 |
|---|---|---|
| At the final treatment visit | -2.55 ± 3.282 | -1.41 ± 4.283 |
| Post-Treatment Week 12 | -1.81 ± 2.624 | -1.76 ± 4.213 |
| Post-Treatment Week 24 | -1.26 ± 3.211 | -1.98 ± 4.363 |
| Post-Treatment Week 52 | -0.30 ± 1.986 | -2.46 ± 4.858 |
| Post-Treatment Week 104 | -0.35 ± 3.306 | -2.80 ± 5.195 |
| Post-Treatment Week 156 | -0.37 ± 3.999 | -2.92 ± 5.249 |
| Post-Treatment Week 208 | -0.88 ± 2.445 | -3.08 ± 5.560 |
| Post-Treatment Week 260 | -1.31 ± 3.706 | -3.08 ± 5.662 |
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.
| percentage of participants | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 97.0 (96.0 to 97.7) |
Collected over All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 203 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 28/1,596 (1.8%) | 40/1,596 (2.5%) | 805/1,596 (50.4%) |
| Event | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| PNEUMONIAInfections and infestations | 2/1596 |
| HEPATOCELLULAR CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1596 |
| ANAEMIABlood and lymphatic system disorders | 1/1596 |
| ANGINA UNSTABLECardiac disorders | 1/1596 |
| PALPITATIONSCardiac disorders | 1/1596 |
| ABDOMINAL PAIN UPPERGastrointestinal disorders | 1/1596 |
| ANAL FISSUREGastrointestinal disorders | 1/1596 |
| ASCITESGastrointestinal disorders | 1/1596 |
| COLITISGastrointestinal disorders | 1/1596 |
| CONSTIPATIONGastrointestinal disorders | 1/1596 |
| Event | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| FATIGUEGeneral disorders | 300/1596 |
| HEADACHENervous system disorders | 291/1596 |
| PRURITUSSkin and subcutaneous tissue disorders | 199/1596 |
| NAUSEAGastrointestinal disorders | 186/1596 |
| INSOMNIAPsychiatric disorders | 179/1596 |
| ASTHENIAGeneral disorders | 165/1596 |
| DIARRHOEAGastrointestinal disorders | 103/1596 |
Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug
| Age, Continuous(years) | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| Mean | 51.2 ± 11.62 |
| Sex: Female, Male(Participants) | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| Female | 800 |
| Male | 796 |
| Race/Ethnicity, Customized(Participants) | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| White | 1544 |
| Black or African American | 10 |
| Asian | 39 |
| American Indian or Alaska Native | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Multiple | 2 |
| HCV Genotype 1 Subtype(Participants) | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| GT1b without cirrhosis | 757 |
| GT1b with compensated cirrhosis | 142 |
| GT1 Non-b without cirrhosis | 597 |
| GT1 Non-b with compensated cirrhosis | 97 |
| Missing | 3 |
| Prior HCV Treatment History(Participants) | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) |
|---|---|
| Treatment Naïve | 782 |
| Treatment Experienced | 814 |
Showing the first 100 of 187 sites across 27 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing, please refer to the link below.
Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Data sharing details ↗ · vivli.org
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dasabuvir