A randomized, adaptive-design dose finding study to assess the antiviral efficacy andsafety of NIM811 administered in combination with Standard of Care (SOC) for 12 weeks in relapsed HCV-1 infected patients

• Conditions: Hepatitis C genotype 1 relapser; MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2009-009995-11-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

o Chronic Hepatitis C infection Genotype 1 with documented histology and biochemical results consistent with compensated chronic hepatitis C
o HCV-RNA should be = 4 x 100000 IU/mL at screening.
o Male and female subjects age 18 to and including 69 years of age, with Chronic Hepatitis C genotype 1
o Recipient of prior long acting interferon (either as PegIntron, Pegasys or albumin-interferon alpha-2b) and ribavirin (either ribavirin or the ribavirin pro-drug, viramidine) treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment , who subsequently becomes serum HCV RNA positive after stopping treatment (relapser”). Patients must have been off all treatment for at least 3 months prior to start study (visit 1). Appropriate documentation of viral load will be provided in the patient’s source documentation for verification of relapse status
o Platelets counts > 150,000 mm3
o No evidence of cirrhosis by any approved method: transient elastography, liver biopsy or Fibrotest, or any future approved validated method
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

o Contraindication to either pegylated interferon or ribavirin
o Pregnant or breast-feeding females
o women of child bearing potential not willing to use 2 methods of contraception
o Hepatic decompensation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified