Phase 4
Completed N=188
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00077649 ↗
Enrolled (actual)
188
Serious AEs
11.2%
Results posted
Apr 2016
Primary outcomePrimary: HCV RNA Profile During The First 24 Weeks — 6.50; 6.61; 6.55; 6.53 log 10 copies/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HCV RNA Profile During The First 24 Weeks |
6.50; 6.61; 6.55; 6.53; 5.80; 5.82 | — |
| PRIMARY Percentage of Participants With Virological Response Over Time to Week 24 |
0.0; 0.0; 0.0; 0.0; 0.00; 0.00 | — |
| PRIMARY Percentage of Participants With Predicted Sustained Virological Response |
40.9; 31.1; 47.7; 50.0 | — |
| SECONDARY Percentage of Participants With Sustained Virological Response |
28.3; 31.9; 36.2; 46.8 | — |
| SECONDARY Percentage of Participants With Virological Response at the End of the Treatment Period |
45.7; 57.4; 55.3; 55.3 | — |
| SECONDARY Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period |
28.3; 29.8; 34.0; 46.8 | — |
| SECONDARY Percentage of Participants With Adverse Events and Serious Adverse Events |
100; 100; 100; 100; 9; 13 | — |
| SECONDARY Percentage of Participants With Marked Laboratory Abnormalities |
44; 53; 41; 64; 42; 57 | — |
| SECONDARY Percentage of Participants With Abnormal Vital Signs |
0; 0; 0; 0; 0; 2 | — |
| SECONDARY Total BDI-II (Beck Depression Inventory) Scores |
3.52; 4.39; 4.23; 4.43; 4.24; 4.45 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- body weight >85kg (187lbs);
- CHC (genotype 1);
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women.
Exclusion Criteria
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection;
- previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
Data sourced from ClinicalTrials.gov (NCT00077649). 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.