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Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)
Phase 4 trial testing PEG-IFN alfa-2b in Hepatitis C, Chronic in 45 participants. Terminated before completion.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 1 January 2013 |
| Primary completion | 26 January 2015 |
| Estimated completion | 26 January 2015 |
Merck Sharp & Dohme LLC — 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.
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
| Group | Value | 95% CI |
|---|---|---|
| 44 Weeks of PEG-IFN Alfa-2b + RBV | 13 | |
| 20 Weeks of PEG-IFN Alfa-2b + RBV | 22 |
Time frame: Up to 72 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 44 Weeks of PEG-IFN Alfa-2… | 20 Weeks of PEG-IFN Alfa-2… |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Leukopaenia | Blood and lymphatic system disorders | — | — |
| Reaction | System | 44 Weeks of PEG-IFN Alfa-2… | 20 Weeks of PEG-IFN Alfa-2… |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Fatigue | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Blood thyroid stimulating hormone increased | Investigations | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Anemia, Leukopaenia.
Data from ClinicalTrials.gov NCT01606800 adverse events section.
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.
No peer-reviewed publications indexed yet for this trial.
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