Phase 2
Completed N=357
Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
Source: ClinicalTrials.gov NCT00160251 ↗Enrolled (actual)
357
Serious AEs
6.0%
Results posted
Dec 2011
Primary outcomePrimary: Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT) — 35.0; 6.3; 16.3; 13.4 Percent of participants
Summary
The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT) |
35.0; 6.3; 16.3; 13.4; 20.4; 21.5 | — |
| PRIMARY Percent of Participants Who Achieved Sustained Virologic Response (SVR) |
7.5; 2.1; 12.2; 5.2; 14.3; 4.6 | — |
| SECONDARY Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA |
58; 33; 33; 0 | — |
| SECONDARY Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop |
9.5; 16.7; 1; 1.8; 17.6; 18.8 | — |
| SECONDARY Percent of Participants With Virologic Response Prior to Amendment 2 |
4.1; 0.0; 0.0; 0; 5.2; 4.6 | — |
| SECONDARY Peak Plasma Concentration of Boceprevir (BOC) |
203; 427; 704; 1312 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period |
1042; 2184; 3633; 6276 | — |
| SECONDARY Trough Plasma Concentration Level |
56.7; 133.0; 214.0; 355 | — |
| SECONDARY Change in Alanine Aminotransferase (ALT) Levels |
14; 33; 45; 43; 47; 84 | — |
| SECONDARY Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks]) |
0; 0; 0; 4; 11; 2 | — |
| SECONDARY Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5) |
0; 0; 3; 12; 1; 0 | — |
| SECONDARY Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7) |
0; 0; 0; 0; 5; 7 | — |
Eligibility Criteria
Key inclusion criteria
- Documented infection with chronic hepatitis C (CHC), genotype 1.
- Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)
- No evidence of cirrhosis on liver biopsy.
- Results of physical examination and laboratory tests within specified ranges.
- Abstinence from use of abused substances.
Key exclusion criteria
- Women who are pregnant or nursing a child.
- Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).
- Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.
- Patients who relapsed following response to previous treatment.
- Evidence of advanced liver disease, or liver disease from a cause other than CHC.
- Pre-existing psychiatric condition.
Data sourced from ClinicalTrials.gov (NCT00160251). 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.