Safety,Tolerability and Pharmacokinetic Study of Recombinant Human Interferon Alfa 2B in Chronic Hepatitis C Patients (HM10660A)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• Male or female, aged 18 to 65 years old, inclusive

• Willing and able to provide written informed consent.

• Previously untreated HCV infection with HCV RNA > 75,000 IU/mL at screening.

• HCV genotype 1a or 1b.

• Body mass index (BMI) between 18 and 38 kg/m2.

• Willing and able to comply with the protocol and available to complete the study schedule of assessments.

Exclusion Criteria:

• Pregnant women or women who may wish to become pregnant during the course of the study.

• Males and females of reproductive potential who are unwilling to use 2 forms of effective birth control throughout the duration of study treatment and for at least 6 months after the last dose of RBV. One method should include a condom with spermicide for males. Males must agree to refrain from sperm donation for at least 6 months after the last dose of RBV.

• Evidence of infection or co-infection with a non-genotype 1 HCV strain.

• Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

• Lactating females