Hepatitis CPhase 3NCT00004804
Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
A Phase 3 study testing interferon alfa in people with Hepatitis C, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C. II. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- interferon alfa
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Aug 1993to not given
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative
- No decompensated cirrhosis
--Prior/Concurrent Therapy--
- No concurrent immunosuppressives At least 1 year since interferon
--Patient Characteristics--
- Hepatic: No other cause of liver disease
- Other: Not HIV positive
About this study
OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C.
II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.
Read the detailed description
PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio.
The first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued.
The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.
- Conditions
- Hepatitis C
- Being tested
- interferon alfa
- Keywords
- hepatitis C, immunologic disorders and infectious disorders, rare disease, viral infection
- Medical subject headings
- Hepatitis C, Immune System Diseases, Communicable Diseases, Rare Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon alfaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startAug 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Enrolment
- 57 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Tulane University School of Medicine
- Investigators
- Anna S. F. Lok, Study chair, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004804
- Sponsor's protocol ID
- 199/11964
- Other IDs
- TUMC-M1260
- Status last verified
- Feb 1997
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00004804
- Acronym / sponsor ID
- 199/11964
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, immunologic disorders and infectious disorders, rare disease, viral infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Tulane University School of Medicine
- Study start
- Aug 1993
- First posted
- 25 Feb 2000 (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.
OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C.
II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.
Detailed description
PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio.
The first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued.
The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| interferon alfa | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
Related trials for Hepatitis C
RecruitingObservational study
Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis
Hepatitis, Teleradiology
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
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.
Anna S. F. Lok study chair
Tulane University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing interferon alfa in people with Hepatitis C, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2005. 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.
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 24 Jun 2005.