Hepatitis CPhase 3NCT00249860
A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
A Phase 3 study testing Interferon-beta-1a and Ribavirin plus Interferon-beta-1a in people with Hepatitis C, run by EMD Serono.
Trial summary
The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Interferon-beta-1a and Ribavirin plus Interferon-beta-1a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Aug 2005
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal
- Had adequate bone marrow reserve and organ function
- Are not pregnant and are willing to use contraception, if, of childbearing potential
- Are willing and able to comply with the protocol and to give written informed consent
- Other protocol defined inclusion criteria may apply
Who cannot join
- Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy
- History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures
- Any cause for the liver disease other than chronic hepatitis C
- Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse
- Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody
- Previous systemic treatment for Hepatitis C with an interferon or ribavirin
Show all 11Show fewer
- Presence of systemic disease that might interfere with subject safety, compliance or evaluation
- Known allergies to acetaminophen, human serum albumin or mannitol;
- Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment
- Bearing organ transplants (except cornea)
- Other protocol defined exclusion criteria may apply
About this study
Official title: A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy.
This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks.
The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).
- Conditions
- Hepatitis C
- Being tested
- Interferon-beta-1a, Placebo, Ribavirin plus Interferon-beta-1a
- Keywords
- Subjects with chronic hepatitis C who have never previously received interferon therapy.
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-beta-1aDrug
Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
PlaceboDrug
Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24
Ribavirin plus Interferon-beta-1aDrug
Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
| Study group | Role | What they receive |
|---|---|---|
| Interferon-beta-1a | Experimental | Not described Receives: Drug: Interferon-beta-1a |
| Ribavarin plus interferon-beta-1a | Active comparator | Not described Receives: Drug: Placebo; Drug: Ribavirin plus Interferon-beta-1a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving sustained viral response (SVR) at Week 24
Measured: Week 24
Percentage of subjects achieving sustained viral response (SVR) at Week 48
Measured: Week 48
Secondary outcomes (7)
Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
Measured: Baseline, Week 12, 24, and 48
Percentage of subjects with Alanine transaminase (ALT) normalization
Measured: Week 12, 24, and 48
Percentage of subjects with viral clearance
Measured: Week 12 and 24
Percentage of subjects with both SVR and sustained ALT normalization
Measured: Week 48
Number of subjects with improvement in the liver necroinflammation score by at least two points
Measured: Week 48
Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
Measured: Week 48
Number of subjects with adverse events and serious adverse events
Measured: Baseline up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startSep 2002
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Pte. Ltd., Singapore
- Responsible party
- Sponsor
- Investigators
- Theodor Wee, M.D., Study director, Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249860
- Sponsor's protocol ID
- 23744
- Status last verified
- Aug 2013
- First submitted
- 4 Nov 2005
- Last updated
- 6 Aug 2013
- Results posted
- No
Publications
Chan HL, Ren H, Chow WC, Wee T; Interferon beta-1a Hepatitis C Study Group. Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C. Hepatology. 2007 Aug;46(2):315-23. doi: 10.1002/hep.21683.
PubMed 17654600
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
- ClinicalTrials.gov ID
- NCT00249860
- Acronym / sponsor ID
- 23744
- Conditions
- Hepatitis C
- Keywords
- Subjects with chronic hepatitis C who have never previously received interferon therapy.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Pte. Ltd., Singapore
- Study start
- Sep 2002
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 7 Nov 2005 (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.
The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy.
This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks.
The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon-beta-1a | Experimental | Drug: Interferon-beta-1a |
| Ribavarin plus interferon-beta-1a | Active comparator | Drug: Placebo, Drug: Ribavirin plus Interferon-beta-1a |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal
- Had adequate bone marrow reserve and organ function
- Are not pregnant and are willing to use contraception, if, of childbearing potential
- Are willing and able to comply with the protocol and to give written informed consent
Key exclusion criteria (11 listed)
- Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy
- History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures
- Any cause for the liver disease other than chronic hepatitis C
- Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse
- Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody
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-beta-1aInterferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24 | Drug | Interferon-beta-1a |
| PlaceboMatching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24 | Drug | Ribavarin plus interferon-beta-1a |
| Ribavirin plus Interferon-beta-1aPlacebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24 | Drug | Ribavarin plus interferon-beta-1a |
Primary outcome
Percentage of subjects achieving sustained viral response (SVR) at Week 24
Time frame: Week 24
Percentage of subjects achieving sustained viral response (SVR) at Week 48
Time frame: Week 48
7 secondary outcomes
Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
Time frame: Baseline, Week 12, 24, and 48
Percentage of subjects with Alanine transaminase (ALT) normalization
Time frame: Week 12, 24, and 48
Percentage of subjects with viral clearance
Time frame: Week 12 and 24
Percentage of subjects with both SVR and sustained ALT normalization
Time frame: Week 48
Number of subjects with improvement in the liver necroinflammation score by at least two points
Time frame: Week 48
Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
Time frame: Week 48
Number of subjects with adverse events and serious adverse events
Time frame: Baseline up to Week 48
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 6 Aug 2013.
- Results publication: PubMed 17654600Chan HL, Ren H, Chow WC, Wee T; Interferon beta-1a Hepatitis C Study Group. Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C. Hepatology. 2007 Aug;46(2):315-23. doi: 10.1002/hep.21683.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
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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.
Theodor Wee, M.D. study director
Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon-beta-1a and Ribavirin plus Interferon-beta-1a in people with Hepatitis C, run by EMD Serono.
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 11 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 6 Aug 2013. 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?
Percentage of subjects achieving sustained viral response (SVR) at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249860, which also lists 1 linked publication.
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 6 Aug 2013.