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A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Phase 4 trial testing peginterferon alfa-2a [Pegasys] in Hepatitis C, Chronic in 1,013 participants. Completed in 10 June 2013.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,013 |
| Start date | 25 September 2008 |
| Primary completion | 10 June 2013 |
| Estimated completion | 10 June 2013 |
| Sites | 26 locations across Israel |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Hepatitis C, Chronic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
| Group | Value | 95% CI |
|---|---|---|
| Pegylated Interferon Alfa 2a (Peginterferon) | 15.7 | 12.6 – 18.1 |
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
| Group | Value | 95% CI |
|---|---|---|
| Pegylated Interferon Alfa 2a (Peginterferon) | 50.8 | 46.8 – 54.4 |
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
| Group | Value | 95% CI |
|---|---|---|
| Pegylated Interferon Alfa 2a (Peginterferon) | 15.6 | 12.9 – 19.2 |
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Pegylated Interferon Alfa 2a (Peginterferon) | 48.03 | 42.3 – 53.6 |
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
| Group | Value | 95% CI |
|---|---|---|
| Pegylated Interferon Alfa 2a (Peginterferon) | 51.97 | 46.2 – 57.6 |
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
| Group | Value | 95% CI |
|---|---|---|
| Pegylated Interferon Alfa 2a (Peginterferon) | 6.9 | 4.3 – 10.3 |
Time frame: Baseline to Week 24. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pegylated Interferon Alfa … |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Pancytopenia | Blood and lymphatic system disorders | — |
| Pneumonia | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Asthenia | General disorders | — |
| Appendicitis | Infections and infestations | — |
| Haemolytic anemia | Blood and lymphatic system disorders | — |
| Neutropenic fever | Blood and lymphatic system disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Optic nerve disorder | Eye disorders | — |
| Optic Neuropathy | Eye disorders | — |
| Retinal haemorrhage | Eye disorders | — |
| Uveitis | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Abdominal pain lower | Gastrointestinal disorders | — |
| pancreatitis | Gastrointestinal disorders | — |
| Pancreatitis acute | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Chest pain | General disorders | — |
| Oedema Peripheral | General disorders | — |
| Pyrexia | General disorders | — |
| Jaundice cholestatic | Hepatobiliary disorders | — |
| Abdominal wall abcess | Infections and infestations | — |
| Cellulitis | Infections and infestations | — |
| Reaction | System | Pegylated Interferon Alfa … |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Asthenia | General disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
Most-reported serious reactions: Anemia, Pancytopenia, Pneumonia, Urinary tract infection, Acute myocardial infarction, Asthenia, Appendicitis, Haemolytic anemia.
Data from ClinicalTrials.gov NCT01429792 adverse events section.
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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