A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with RBV. The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with RBV.

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

Details

• Lead Sponsor: HanAll BioPharma Co., Ltd.
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Diagnosis of chronic hepatitis C genotype 1a or 1b

• Male or female aged 18 to 65 years, inclusive

• Compensated liver disease without evidence of cirrhosis

• No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome

• No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies

• Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia

Exclusion Criteria:

• History of previous treatment of hepatitis C

• Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis

• History or presence of chronic liver disease

• History of drug or alcohol abuse within the past year

• Evidence of active illicit drug use

• Clinically significant abnormal electrocardiogram (ECG) or rhythm strip

• Female subject who has a positive urine pregnancy test or who is lactating