Chronic Hepatitis CPhase 2NCT00084279
CIFN and IFN γ-1b With or Without Ribavirin for Treatment of Chronic Hepatitis C (Nonresponders)
A Phase 2 study testing Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin in people with Chronic Hepatitis C, run by InterMune at 1 site in United States.
Trial summary
To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin
- Type of treatment
- Pill or oral medicine
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 2006
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed
- Male or female 18 years of age or older
- Chronic hepatitis C infection based on history of positive serum anti-HCV antibody and/or HCV RNA
- Patients must have documented failure to respond to past treatment with PEG-Intron or Pegasys plus RBV.
- Liver biopsy within 3 years of screening documenting chronic liver disease consistent with chronic hepatitis C
Who cannot join
- Patients with any history of decompensated liver disease including but not restricted to portal hypertension as manifested by gastroesophageal varices, variceal bleeding, ascites, or encephalopathy
- Specific laboratory abnormalities at Screening
- Patients who were HCV RNA negative during prior pegylated interferon plus ribavirin treatment, but who relapsed during follow-up
- Recent depression or psychiatric disorders
- Known HIV infection or positive HIV antibody test at Screening
- Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at Screening
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- Unstable or uncontrolled thyroid disease
- Presence or history of non-HCV chronic liver disease
- History of unstable or deteriorating cardiovascular or cerebrovascular disease within 6 months prior to Screening
- Current or history of neurologic disorder within a specified time frame
- A disease known to cause significant alteration in immunologic function including hematological malignancy, sarcoidosis or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, leukemia, lymphoma, autoimmune thyroid disease, scleroderma, psoriasis, inflammatory bowel disease, multiple sclerosis etc.)
- History of major organ transplantation (i.e., liver, kidney, lung, or heart) with an existing functional graft, including bone marrow transplant or stem cell transplant
- Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as cyclosporine, azathioprine, chronic systemic corticosteroids, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
- Pregnant or lactating women
- Liver biopsy within the past three years documenting cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tolerability of Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV) in the Treatment of Patients With Chronic Hepatitis C Who Are Non-Responders to PEG-IFN-a (2a or 2b) Plus RBV
To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.
- Conditions
- Chronic Hepatitis C
- Being tested
- Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin
- Keywords
- Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Gamma, Ribavirin, Combination, Nonresponder, Pegasys, PegIntron
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consensus Interferon-Alpha, Interferon Gamma-1b, RibavirinDrug
interferon gamma-1b: 0.25 and 0.5 mL, SQ, 3x per week interferon alfacon: 0.3 mL and 0.5 mL, SQ, once a day Ribavirin: 2 capsules in a.m., 3 capsules in p.m.; daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic response defined as >2 log (base 10) reduction in HCV RNA
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startApr 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterMune
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matthew McClure, MD, Study director, InterMune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084279
- Sponsor's protocol ID
- AGHC-002
- Status last verified
- Jul 2009
- First submitted
- 9 Jun 2004
- Last updated
- 3 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV) in the Treatment of Patients With Chronic Hepatitis C Who Are Non-Responders to PEG-IFN-a (2a or 2b) Plus RBV
- ClinicalTrials.gov ID
- NCT00084279
- Acronym / sponsor ID
- AGHC-002
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Gamma, Ribavirin, Combination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- InterMuneIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 11 Jun 2004 (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.
To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed
- Male or female 18 years of age or older
- Chronic hepatitis C infection based on history of positive serum anti-HCV antibody and/or HCV RNA
- Patients must have documented failure to respond to past treatment with PEG-Intron or Pegasys plus RBV.
- Liver biopsy within 3 years of screening documenting chronic liver disease consistent with chronic hepatitis C
Key exclusion criteria (15 listed)
- Patients with any history of decompensated liver disease including but not restricted to portal hypertension as manifested by gastroesophageal varices, variceal bleeding, ascites, or encephalopathy
- Specific laboratory abnormalities at Screening
- Patients who were HCV RNA negative during prior pegylated interferon plus ribavirin treatment, but who relapsed during follow-up
- Recent depression or psychiatric disorders
- Known HIV infection or positive HIV antibody test at Screening
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 |
|---|---|---|
| Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirininterferon gamma-1b: 0.25 and 0.5 mL, SQ, 3x per week interferon alfacon: 0.3 mL and 0.5 mL, SQ, once a day Ribavirin: 2 capsules in a.m., 3 capsules in p.m.; daily | Drug | – |
Primary outcome
Virologic response defined as >2 log (base 10) reduction in HCV RNA
Time frame: 72 weeks
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 3 Jul 2009.
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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.
Matthew McClure, MD study director
InterMune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin in people with Chronic Hepatitis C, run by InterMune at 1 site 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 5 inclusion and 15 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 3 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
Virologic response defined as >2 log (base 10) reduction in HCV RNA (time frame: 72 weeks). 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 3 Jul 2009.