A Phase 3 interventional study of ombitasvir/paritaprevir/ritonavir and dasabuvir and ribavirin in Chronic Hepatitis C Infection, sponsored by AbbVie. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 222 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir · Drug: ribavirin
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
Also known as: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
Tablet
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With SVR12 by Fibrosis Stage
SVR12 was defined as plasma HCV RNA level \<LLOQ\]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.
Time frame: 12 weeks after the last actual dose of study drug
Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.
Time frame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain
Time frame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.
Time frame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
| Milestone | 3-DAA ± RBV |
|---|---|
| Started | 222 |
| Completed | 218 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrew consent | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Other | 1 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.
| percentage of participants | 3-DAA ± RBV |
|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 96.4 (93.1 to 98.2) |
SVR12 was defined as plasma HCV RNA level \<LLOQ\]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.
| percentage of participants | Fibrosis Stage F3 | Fibrosis Stage F4 |
|---|---|---|
| Percentage of Participants With SVR12 by Fibrosis Stage | 96.6 (90.6 to 98.8) | 96.2 (91.5 to 98.4) |
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.
| percentage of participants | Treatment-Naive | Pegylated Interferon (PegIFN)/RBV Null Responders | Pegylated Interferon (PegIFN)//RBV Partial Responders | Pegylated Interferon (PegIFN)/RBV Non-Responders | Pegylated Interferon (PegIFN)/RBV Relapser | Pegylated Interferon (PegIFN)/RBV Breakthrough | IFN Interolerant | Other |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience | 96.1 (90.3 to 98.5) | 95.5 (78.2 to 99.2) | 100 (NA to NA) | 100 (87.1 to 100.0) | 97.1 (85.1 to 99.5) | 100 (78.5 to 100.00) | 85.7 (NA to NA) | 91.7 (64.6 to 98.5) |
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.
| percentage of participants | Interferon (IFN)-Ineligible, Treatment-Naive | Interferon (IFN)-Eligible, Treatment-Naive | Interferon (IFN)-Ineligible, Treatment-Experienced | Interferon (IFN)-Eligible, Treatment-Experienced |
|---|---|---|---|---|
| Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening | 90.0 (59.6 to 98.2) | 96.7 (90.8 to 98.9) | 85.7 (NA to NA) | 97.3 (92.5 to 99.1) |
The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.
| units on a scale | Fibrosis Stage F3 | Fibrosis Stage F4 |
|---|---|---|
| SVR12 Not Achieved | 0.5 ± 10.97 | 0.8 ± 10.64 |
| SVR12 Achieved | 3.8 ± 13.25 | 4.2 ± 15.72 |
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain
| units on a scale | Fibrosis Stage F3 | Fibrosis Stage F4 |
|---|---|---|
| SVR12 Not Achieved | -0.5 ± 9.22 | 1.3 ± 8.59 |
| SVR12 Achieved | 0.1 ± 6.42 | 2.1 ± 7.60 |
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.
| units on a scale | Fibrosis Stage F3 | Fibrosis Stage F4 |
|---|---|---|
| SVR12 Not Achieved | 2.4 ± 3.72 | -0.6 ± 8.47 |
| SVR12 Achieved | 2.4 ± 11.39 | 2.5 ± 9.15 |
Collected over Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3-DAA ± RBV | — | 6/222 (2.7%) | 139/222 (62.6%) |
| Event | 3-DAA ± RBV |
|---|---|
| DIARRHOEAGastrointestinal disorders | 1/222 |
| OESOPHAGEAL VARICES HAEMORRHAGEGastrointestinal disorders | 1/222 |
| HEPATIC FAILUREHepatobiliary disorders | 1/222 |
| GASTROENTERITISInfections and infestations | 1/222 |
| LUNG ADENOCARCINOMA METASTATICNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/222 |
| TRANSIENT ISCHAEMIC ATTACKNervous system disorders | 1/222 |
| RENAL FAILURERenal and urinary disorders | 1/222 |
| Event | 3-DAA ± RBV |
|---|---|
| HEADACHENervous system disorders | 48/222 |
| FATIGUEGeneral disorders | 41/222 |
| NAUSEAGastrointestinal disorders | 34/222 |
| PRURITUSSkin and subcutaneous tissue disorders | 32/222 |
| ASTHENIAGeneral disorders | 20/222 |
| DIARRHOEAGastrointestinal disorders | 19/222 |
| ANAEMIABlood and lymphatic system disorders | 16/222 |
| DYSPEPSIAGastrointestinal disorders | 15/222 |
| COUGHRespiratory, thoracic and mediastinal disorders | 14/222 |
| INSOMNIAPsychiatric disorders | 12/222 |
| Age, Continuous(years) | 3-DAA ± RBV |
|---|---|
| Mean | 56.6 ± 10.34 |
| Sex: Female, Male(Participants) | 3-DAA ± RBV |
|---|---|
| Female | 99 |
| Male | 123 |
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