A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

HanAll Biopharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Genotype 1; Chronic Hepatitis C Infection

Treatments: Drug: Ribavirin; Drug: Peginterferon alfa-2a; Drug: recombinant variant of interferon-alpha 2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT01194037

HL-143IFN-SC-US-001

Details and patient eligibility

About

This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.

Full description

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 ribavirin(RBV). The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with ribavirin(RBV).

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily

Experimental group

Description:

Hanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)

Treatment:

Drug: recombinant variant of interferon-alpha 2b

Drug: Ribavirin

Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily

Experimental group

Description:

Hanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)

Treatment:

Drug: recombinant variant of interferon-alpha 2b

Drug: Ribavirin

Pegasys 180 ug sc weekly + RBV oral daily

Active Comparator group

Description:

Pegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)

Treatment:

Drug: Peginterferon alfa-2a

Drug: Ribavirin