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

Chronic Hepatitis C Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194037
• Other study ID #: HL-143IFN-SC-US-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 1, 2010
• Last updated: February 24, 2014
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2014
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Genotype 1
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• recombinant variant of interferon-alpha 2b
SC, Weekly
• Peginterferon alfa-2a
SC Weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV RNA level		Week 4	No
Secondary	Proportion of patients who reach RVR		Week 4	No
Secondary	PK & PD		Weeks 0 and 3	No