Chronic Hepatitis C InfectionPhase 1/2NCT01194037
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
A Phase 1/2 study testing recombinant variant of interferon-alpha 2b, Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C Infection and Genotype 1, run by HanAll BioPharma Co., Ltd. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C Infection, Genotype 1
- What is being tested?
- recombinant variant of interferon-alpha 2b, Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jun 2011to 28 Nov 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Atlanta, Georgia
Study site
Lexington, Kentucky
Study site
Los Angeles, California, 90036
Study site
Miami, Florida
Study site
National City, California
Study site
New Orleans, Louisiana
About this study
Official title: A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
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.
Read the detailed 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).
- Conditions
- Chronic Hepatitis C Infection, Genotype 1
- Being tested
- recombinant variant of interferon-alpha 2b, Peginterferon alfa-2a, Ribavirin
- Keywords
- Hepatitis C, HCV, Interferon, Hanferon
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant variant of interferon-alpha 2bDrug
Also called Hanferon
SC, Weekly
Peginterferon alfa-2aDrug
Also called Pegasys
SC Weekly
RibavirinDrug
Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing < 75 kg or 1200 mg for subjects weighing ≥ 75 kg)
| Study group | Role | What they receive |
|---|---|---|
| Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily | Experimental | Hanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg) Receives: Drug: recombinant variant of interferon-alpha 2b; Drug: Ribavirin |
| Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily | Experimental | Hanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg) Receives: Drug: recombinant variant of interferon-alpha 2b; Drug: Ribavirin |
| Pegasys 180 ug sc weekly + RBV oral daily | Active comparator | Pegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg) Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA level
Measured: Week 4
Secondary outcomes (2)
Proportion of patients who reach RVR
Measured: Week 4
PK & PD
Measured: Weeks 0 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study start23 Jun 2011
- Primary completion28 Nov 2011
- Study completion28 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194037
- Sponsor's protocol ID
- HL-143IFN-SC-US-001
- Status last verified
- Feb 2014
- First submitted
- 1 Sep 2010
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
- ClinicalTrials.gov ID
- NCT01194037
- Acronym / sponsor ID
- HL-143IFN-SC-US-001
- Conditions
- Chronic Hepatitis C Infection, Genotype 1
- Keywords
- Hepatitis C, HCV, Interferon, Hanferon
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2011 (actual)
- Primary completion
- 28 Nov 2011 (actual)
- Study completion
- 28 Nov 2011 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily | Experimental | Drug: recombinant variant of interferon-alpha 2b, Drug: RibavirinHanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg) |
| Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily | Experimental | Drug: recombinant variant of interferon-alpha 2b, Drug: RibavirinHanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg) |
| Pegasys 180 ug sc weekly + RBV oral daily | Active comparator | Drug: Peginterferon alfa-2a, Drug: RibavirinPegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight < 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant variant of interferon-alpha 2bAlso: HanferonSC, Weekly | Drug | Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily, Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily |
| Peginterferon alfa-2aAlso: PegasysSC Weekly | Drug | Pegasys 180 ug sc weekly + RBV oral daily |
| RibavirinOral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing < 75 kg or 1200 mg for subjects weighing ≥ 75 kg) | Drug | Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily, Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily, Pegasys 180 ug sc weekly + RBV oral daily |
Primary outcome
HCV RNA level
Time frame: Week 4
2 secondary outcomes
Proportion of patients who reach RVR
Time frame: Week 4
PK & PD
Time frame: Weeks 0 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing recombinant variant of interferon-alpha 2b, Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C Infection and Genotype 1, run by HanAll BioPharma Co., Ltd. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV RNA level (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.