Chronic Hepatitis CPhase 3NCT00086541
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
A Phase 3 study testing Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks in people with Chronic Hepatitis C, run by Bausch Health Americas, Inc..
Trial summary
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis C who are nonresponders to previous pegylated interferon… 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?
- Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks
- How many people
- 515 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jan 2007
- Phase
- Phase 3
- 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 informed consent form
- Male or female 18 yrs. of age or older
- Chronic HCV infection based on documented history of positive serum anti-HCV antibody test and/or detectable levels of HCV RNA
- Documented virologic nonresponse to past treatment with PEGASYS plus ribavirin or PEG-Intron plus ribavirin
- Previously treated w/either of the following starting doses of pegylated interferon alpha:
- ≥ 1.5 µg/kg/week PEG-Intron or dose consistent with the package insert or,
Show all 10Show fewer
- ≥ 180 µg/week PEGASYS
- Detectable plasma HCV RNA level at screening visit
- Liver biopsy histologically documenting chronic liver disease consistent with chronic HCV infection
- All patients and all potentially fertile sexual partners of patients must use 2 reliable forms of effective contraception during the study \& for 6 months after cessation of the study drugs
Who cannot join
- Any history of decompensated liver disease
- Any of a variety of laboratory abnormalities assessed through blood sample at screening
- Patients who prematurely discontinued, interrupted, or reduced the dose of their previous pegylated interferon alpha-based combination therapy due to noncompliance or safety and/or tolerability issues
- Patients who had undetectable HCV RNA levels during prior pegylated interferon alfa plus ribavirin treatment but who relapsed during follow-up
- Significant depression in the last 2 years
- Patients treated for HCV infection within 3 months before screening (w/the exclusion of over-the-counter therapies)
Show all 28Show fewer
- Patients who have been on any experimental protocol or therapy within 28 days before screening
- Use of colony-stimulating factor agents or other therapeutic agents that might artificially elevate laboratory parameters within 3 months before screening
- Known human immunodeficiency virus (HIV) infection or positive HIV antibody test at screening
- Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at screening
- New onset diabetes
- Unstable or uncontrolled thyroid disease
- Presence or history of non-HCV chronic liver disease
- History of unstable or deteriorating cardiac or cerebrovascular disease within 6 months before Screening
- Current or history of neurologic disorder within the last 2 years
- History of seizures within the past 5 years
- History of hemoglobinopathies
- History of malignancy within the last 5 years with the exception of localized basal or squamous cell carcinoma \& fully resected, localized malignancy not requiring active treatment \& with no evidence of recurrence
- A disease known to cause significant alteration in immunologic function including hematologic malignancy, sarcoidosis or autoimmune disorder
- History or evidence of retinopathy
- History of major organ transplantation with an existing functional graft
- Concurrent therapy with immunosuppressive drugs or cytotoxic agents
- Alcohol and/or drug abuse w/in the past year, that in the opinion of the Investigator or the Sponsor may negatively affect patient compliance
- Pregnant or lactating women
- Male partners of women who are pregnant
- Known sensitivity to Infergen or IFN-α or to E. coli-derived products
- Patients who, in the opinion of the Investigator or the Sponsor, are not suitable candidates for enrollment or who would not comply w/the requirements of the study
- Patients who have not responded to a course of daily Infergen (9 or 15 µg) with or without ribavirin or who have relapsed after a course of daily Infergen (9 or 15 µg).
About this study
Official title: A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis C who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
Patients are randomized 1:1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both administered daily) or no treatment for up to 48 weeks.
The protocol and informed consent form that will be used must be approved by the Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the study is initiated.
- Conditions
- Chronic Hepatitis C
- Being tested
- Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks
- Keywords
- Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Ribavirin, Combination, Nonresponder, HCV, Infergen, SVR
- 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.
Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
Secondary outcomes (1)
Evaluate safety & tolerability of therapy detailed in primary objective, and proportion of patients with (a) undetectable plasma HCV RNA levels at weeks 24 & 48 (b) abnormal baseline serum ALT levels that are normal at week 24, week 48 and weeks 48 & 72.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2004 (estimated)
- Study startJun 2004
- Study completionJan 2007
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.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralph T. Doyle, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086541
- Sponsor's protocol ID
- IRHC-001
- Other IDs
- DIRECT 1
- Status last verified
- Nov 2019
- First submitted
- 2 Jul 2004
- Last updated
- 25 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy
- ClinicalTrials.gov ID
- NCT00086541
- Acronym / sponsor ID
- IRHC-001
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Liver, Pegylated, Interferon, Alpha, Ribavirin, Combination, Nonresponder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 7 Jul 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.
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis C who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
Patients are randomized 1:1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both administered daily) or no treatment for up to 48 weeks.
The protocol and informed consent form that will be used must be approved by the Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the study is initiated.
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 (10 listed)
- Signed informed consent form
- Male or female 18 yrs. of age or older
- Chronic HCV infection based on documented history of positive serum anti-HCV antibody test and/or detectable levels of HCV RNA
- Documented virologic nonresponse to past treatment with PEGASYS plus ribavirin or PEG-Intron plus ribavirin
- Previously treated w/either of the following starting doses of pegylated interferon alpha:
Key exclusion criteria (28 listed)
- Any history of decompensated liver disease
- Any of a variety of laboratory abnormalities assessed through blood sample at screening
- Patients who prematurely discontinued, interrupted, or reduced the dose of their previous pegylated interferon alpha-based combination therapy due to noncompliance or safety and/or tolerability issues
- Patients who had undetectable HCV RNA levels during prior pegylated interferon alfa plus ribavirin treatment but who relapsed during follow-up
- Significant depression in the last 2 years
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 |
|---|---|---|
| Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks | Drug | – |
Primary outcome
Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
1 secondary outcome
Evaluate safety & tolerability of therapy detailed in primary objective, and proportion of patients with (a) undetectable plasma HCV RNA levels at weeks 24 & 48 (b) abnormal baseline serum ALT levels that are normal at week 24, week 48 and weeks 48 & 72.
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 25 Nov 2019.
Related trials for Chronic Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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.
Ralph T. Doyle study director
Bausch Health Americas, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks in people with Chronic Hepatitis C, run by Bausch Health Americas, Inc..
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 10 inclusion and 28 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.. 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 25 Nov 2019.