N/A
Completed N=538
Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00709059 ↗
Enrolled (actual)
538
Serious AEs
—
Results posted
Jan 2011
Primary outcomePrimary: Number of Study Participants Who Had a Virological Response (VR) at Week-72 — 176 Participants
Summary
The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Study Participants Who Had a Virological Response (VR) at Week-72 |
176 | — |
Eligibility Criteria
Inclusion Criteria
- Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
- Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
- Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase [ALT]) levels above the upper normal limit for gender
- Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
- A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4
Exclusion Criteria
- Known hypersensitivity for any active ingredient or constituent
- Pregnancy or lactation
- Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
- Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
- Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance <50 mL/minute
- Hepatitis of immunologic origin or medically documented history of auto-immune disease
- Severe hepatic disorder or decompensated cirrhosis
- Pre-existing thyroid disorder, except if under control with classical treatment
- Epilepsy or central nervous system disorder
- Hemoglobin pathology, eg, thalassaemia, sickle cell anemia
Data sourced from ClinicalTrials.gov (NCT00709059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.