An observational study in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 9 sites in Bulgaria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-10.
Sponsored by Hoffmann-La Roche · Observational
This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 443 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
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Patients with chronic hepatitis C treated with Pegasys and ribavirin
Exclusion Criteria:
Percentage of Participants With Sustained Virological Response (SVR)
SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction \[PCR\] measured greater than or equal to \>=140 days post-treatment).
Time frame: 24 weeks after End of treatment (EOT) (up to Week 96)
Percentage of Participants With Relapse
Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.
Time frame: Up to 24 weeks after EOT (up to Week 96)
Percentage of Participants Who Were Non-Responders
Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.
Time frame: Up to 24 weeks after EOT (up to Week 96)
Percentage of Participants With Positive Predictive Value on SVR at Week 4
Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.
Time frame: Week 4
Percentage of Participants With Positive Predictive Value on SVR at Week 12
Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.
Time frame: Week 12
Correlation of SVR With Rapid Virological Response (RVR)
Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.
Time frame: Up to 24 weeks after EOT (up to Week 96)
Correlation of SVR With Early Virological Response (EVR)
Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.
Time frame: Up to 24 weeks after EOT (up to Week 96)
Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response
Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.
Time frame: Week 4 and 12
Duration of Treatment in Participants With SVR by HCV Genotype
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Time frame: Up to Week 72
Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Time frame: Up to Week 72
Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
Time frame: Up to Week 72
Percentage of Participants With Virological Response
The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.
Time frame: 4 weeks after EOT (up to Week 76)
| Milestone | Hepatitis C Virus (HCV) Infected Participants |
|---|---|
| Started | 443 |
| Completed | 242 |
| Not completed | 201 |
| Withdrew: Premature study termination | 42 |
| Withdrew: Failure to return | 35 |
| Withdrew: No treatment/no cooperation/withdrew | 12 |
| Withdrew: Lost to follow-up | 34 |
| Withdrew: Insufficient therapeutic response (itr) | 30 |
| Withdrew: Itr and protocol deviation | 1 |
| Withdrew: Adverse event/intercurrent illness | 17 |
| Withdrew: Protocol violation | 14 |
| Withdrew: Other | 3 |
| Withdrew: Missing information | 13 |
SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction \[PCR\] measured greater than or equal to \>=140 days post-treatment).
| percentage of participants | HCV Infected Participants |
|---|---|
| Percentage of Participants With Sustained Virological Response (SVR) | 38.7 |
Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.
| percentage of participants | HCV Infected Participants |
|---|---|
| Percentage of Participants With Relapse | 8.2 |
Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.
| percentage of participants | HCV Infected Participants |
|---|---|
| Percentage of Participants Who Were Non-Responders | 25.1 |
Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.
| percentage of participants | HCV Infected Participants |
|---|---|
| Treatment naive(n=182) | 64.8 |
| Failed previous treatment(n=5) | 20.0 |
Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.
| percentage of participants | HCV Infected Participants |
|---|---|
| Treatment naive(n=182) | 69.8 |
| Failed previous treatment(n=4) | 25.0 |
Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.
| correlation coefficient | HCV Infected Participants |
|---|---|
| Kendall's tau-b | 0.378 |
| Kendall's tau-c | 0.310 |
| Gamma | 0.782 |
Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.
| correlation coefficient | HCV Infected Participants |
|---|---|
| Kendall's tau-b | 0.570 |
| Kendall's tau-c | 0.470 |
| Gamma | 1.000 |
Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.
| predictive value | HCV Infected Participants |
|---|---|
| Week 4: RVR | 2.540 |
| Week 4: gender | 1.390 |
| Week 4: liver fibrosis | 7.030 |
| Week 4: HCV genotype | 2.320 |
| Week 4: height | -0.091 |
| Week 4: treatment duration | 0.020 |
| Week 12: EVR | 5.860 |
| Week 12: gender | 1.291 |
| Week 12: liver fibrosis | 4.774 |
| Week 12: height | -0.071 |
| Week 12: treatment duration | 0.006 |
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
| days | HCV Infected Participants |
|---|---|
| HCV genotype 1(n=111) | 329.95 (116.00 to 365.00) |
| HCV genotype 3(n=16) | 173.25 (140.00 to 337.00) |
| HCV genotype 4(n=1) | 335.00 (335.00 to 335.00) |
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
| µg | HCV Infected Participants |
|---|---|
| HCV genotype 1(n=111) | 24701.70 (6711.43 to 28157.14) |
| HCV genotype 3(n=16) | 13030.71 (10800.00 to 25997.14) |
| HCV genotype 4(n=1) | 25842.86 (25842.86 to 25842.86) |
SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.
| mg | HCV Infected Participants |
|---|---|
| HCV genotype 1(n=111) | 1062607 (348000.00 to 1314000) |
| HCV genotype 3(n=16) | 538812.50 (100800.00 to 1011000) |
| HCV genotype 4(n=1) | 1005000 (1005000 to 1005000) |
The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.
| percentage of participants | HCV Infected Participants |
|---|---|
| Percentage of Participants With Virological Response | 46.8 |
Collected over 24 weeks after EOT (up to Week 96). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HCV Infected Participants | — | 17/440 (3.9%) | 273/440 (62%) |
| Event | HCV Infected Participants |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 4/440 |
| PyrexiaGeneral disorders | 2/440 |
| Anaemia haemolyticBlood and lymphatic system disorders | 1/440 |
| AsteniaBlood and lymphatic system disorders | 1/440 |
| LeucopeniaBlood and lymphatic system disorders | 1/440 |
| NeutropeniaBlood and lymphatic system disorders | 1/440 |
| Angina pectorisCardiac disorders | 1/440 |
| TachycardiaCardiac disorders | 1/440 |
| Chronic gastritisGastrointestinal disorders | 1/440 |
| NauseaGastrointestinal disorders | 1/440 |
| Event | HCV Infected Participants |
|---|---|
| LeucopeniaBlood and lymphatic system disorders | 115/440 |
| AnaemiaBlood and lymphatic system disorders | 114/440 |
| ThrombocytopeniaBlood and lymphatic system disorders | 111/440 |
| FeverGeneral disorders | 68/440 |
| FatigueGeneral disorders | 31/440 |
Intent-to-treat (ITT) population included all screened participants.
| Age, Continuous(years) | HCV Infected Participants |
|---|---|
| Mean | 40.61 ± 12.32 |
| Sex: Female, Male(Participants) | HCV Infected Participants |
|---|---|
| Female | 182 |
| Male | 261 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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