A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
NCT ID: NCT01194037
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2011-06-23
2011-11-28
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily
Hanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
recombinant variant of interferon-alpha 2b
SC, Weekly
Ribavirin
Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing \< 75 kg or 1200 mg for subjects weighing ≥ 75 kg)
Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily
Hanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
recombinant variant of interferon-alpha 2b
SC, Weekly
Ribavirin
Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing \< 75 kg or 1200 mg for subjects weighing ≥ 75 kg)
Pegasys 180 ug sc weekly + RBV oral daily
Pegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
Peginterferon alfa-2a
SC Weekly
Ribavirin
Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing \< 75 kg or 1200 mg for subjects weighing ≥ 75 kg)
Interventions
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recombinant variant of interferon-alpha 2b
SC, Weekly
Peginterferon alfa-2a
SC Weekly
Ribavirin
Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing \< 75 kg or 1200 mg for subjects weighing ≥ 75 kg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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HanAll BioPharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
National City, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Countries
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Other Identifiers
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HL-143IFN-SC-US-001
Identifier Type: -
Identifier Source: org_study_id
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