Hepatitis CPhase 2/3NCT03537274
Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)
A Phase 2/3 study testing PEG-Intron and Interferon Alfa-2B in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon. Participants are randomized to receive one of three doses of PEG-Intron (0.5, 1.0, and 1.5 mg/kg) or Interferon Alfa-2B for 48 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- PEG-Intron and Interferon Alfa-2B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,224 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 1997to 23 Jul 1999
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be serum positive for hepatitis C virus.
- Have liver biopsy within 1 year prior to entry, with a pathology report confirming a histological diagnosis consistent with chronic hepatitis.
- Have one abnormal historic ALT at least 6 months prior to screening, with elevated ALT at entry.
- Have compensated liver disease, testing negative for HIV and serum hepatitis B surface antigen (HBsAg) at entry.
- If male or female of childbearing potential, be practicing adequate contraception during treatment.
Who cannot join
- Be female who is currently pregnant or nursing.
- Have prior treatment with any interferon.
- Have suspected hypersensitivity to alpha interferon.
- Have participated in any other clinical trial within 30 days of entry
- Have received treatment with any investigational drug within 30 days of entry.
- Have received prior treatment for hepatitis with any other antiviral or immunomodulatory drug within the previous 2 years.
Show all 22Show fewer
- Have any other cause for the liver disease other than chronic hepatitis C including but not limited to: co-infection with hepatitis B virus; Hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease; and drug-related liver disease.
- Have hemophilia or any other condition that would prevent the participant from having a liver biopsy, including anticoagulant therapy.
- Have hemoglobinopathies (e.g., Thalassemia)
- Have evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy.
- Have received organ transplants.
- Have a preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or attempt.
- Have central nervous system trauma or active seizure disorders requiring medication.
- Have significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia).
- Have poorly controlled diabetes mellitus.
- Have chronic pulmonary disease (e.g., chronic obstructive pulmonary disease).
- Have immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis).
- Have any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- Have history of substance abuse, such as alcohol, intravenous drugs and inhaled drugs.
- Have clinically significant retinal abnormalities.
- Be unable to abstain from the consumption of alcohol.
- Have any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the protocol.
About this study
Official title: Comparison of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) vs. Interferon Alfa-2B for Treatment of Adult Subjects With Chronic Hepatitis C Not Previously Treated With Interferon: Dose Finding Study
This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon. Participants are randomized to receive one of three doses of PEG-Intron (0.5, 1.0, and 1.5 mg/kg) or Interferon Alfa-2B for 48 weeks. The primary objective of this study is to evaluate the efficacy of PEG-Intron (compared to Interferon Alfa-2B) with respect to response based on loss of detectable HCV ribonucleic acid (HCV-RNA) and normalization of alanine transaminase (ALT) level after 24 weeks of therapy and at 24 weeks of follow-up.
- Conditions
- Hepatitis C
- Being tested
- PEG-Intron, Interferon Alfa-2B
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IntronBiological
Also called SCH 54031
PEG-Intron is administered QW for 48 weeks by SC injection at 0.5, 1.0, and 1.5 mg/kg body weight. Body weight obtained at the baseline visit is used to calculate dosing.
Interferon Alfa-2BBiological
Interferon alfa-2b is administered TIW for 48 weeks by SC injection at 3 MIU regardless of participant body weight.
| Study group | Role | What they receive |
|---|---|---|
| PEG-Intron, 0.5 mg/kg | Experimental | PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection. Receives: Biological: PEG-Intron |
| PEG-Intron, 1.0 mg/kg | Experimental | PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection. Receives: Biological: PEG-Intron |
| PEG-Intron, 1.5 mg/kg | Experimental | PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection. Receives: Biological: PEG-Intron |
| Interferon Alfa-2b | Active comparator | Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection. Receives: Biological: Interferon Alfa-2B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Responder Status at 24 Weeks of Treatment
The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as <100 copies/mL serum by quantitative polymerase chain reaction [qPCR] assay); and 2) alanine transaminase (ALT) level normal.
Measured: Up to 24 weeks
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up
The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as <100 copies/mL serum by qPCR assay); and 2) ALT level normal.
Measured: Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start5 Aug 1997
- Primary completion23 Jul 1999
- Study completion23 Jul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537274
- Sponsor's protocol ID
- C97010
- Other IDs
- MK-4031-016, C97010
- Status last verified
- Jan 2019
- First submitted
- 15 May 2018
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) vs. Interferon Alfa-2B for Treatment of Adult Subjects With Chronic Hepatitis C Not Previously Treated With Interferon: Dose Finding Study
- ClinicalTrials.gov ID
- NCT03537274
- Acronym / sponsor ID
- C97010
- Conditions
- Hepatitis C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,224 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 1997 (actual)
- Primary completion
- 23 Jul 1999 (actual)
- Study completion
- 23 Jul 1999 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 9 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon. Participants are randomized to receive one of three doses of PEG-Intron (0.5, 1.0, and 1.5 mg/kg) or Interferon Alfa-2B for 48 weeks. The primary objective of this study is to evaluate the efficacy of PEG-Intron (compared to Interferon Alfa-2B) with respect to response based on loss of detectable HCV ribonucleic acid (HCV-RNA) and normalization of alanine transaminase (ALT) level after 24 weeks of therapy and at 24 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEG-Intron, 0.5 mg/kg | Experimental | Biological: PEG-IntronPEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection. |
| PEG-Intron, 1.0 mg/kg | Experimental | Biological: PEG-IntronPEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection. |
| PEG-Intron, 1.5 mg/kg | Experimental | Biological: PEG-IntronPEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection. |
| Interferon Alfa-2b | Active comparator | Biological: Interferon Alfa-2BInterferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be serum positive for hepatitis C virus.
- Have liver biopsy within 1 year prior to entry, with a pathology report confirming a histological diagnosis consistent with chronic hepatitis.
- Have one abnormal historic ALT at least 6 months prior to screening, with elevated ALT at entry.
- Have compensated liver disease, testing negative for HIV and serum hepatitis B surface antigen (HBsAg) at entry.
- If male or female of childbearing potential, be practicing adequate contraception during treatment.
Key exclusion criteria (22 listed)
- Be female who is currently pregnant or nursing.
- Have prior treatment with any interferon.
- Have suspected hypersensitivity to alpha interferon.
- Have participated in any other clinical trial within 30 days of entry
- Have received treatment with any investigational drug within 30 days of entry.
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 |
|---|---|---|
| PEG-IntronAlso: SCH 54031PEG-Intron is administered QW for 48 weeks by SC injection at 0.5, 1.0, and 1.5 mg/kg body weight. Body weight obtained at the baseline visit is used to calculate dosing. | Biological | PEG-Intron, 0.5 mg/kg, PEG-Intron, 1.0 mg/kg, PEG-Intron, 1.5 mg/kg |
| Interferon Alfa-2BInterferon alfa-2b is administered TIW for 48 weeks by SC injection at 3 MIU regardless of participant body weight. | Biological | Interferon Alfa-2b |
Primary outcome
Number of Participants Achieving Responder Status at 24 Weeks of Treatment
Time frame: Up to 24 weeks
The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as <100 copies/mL serum by quantitative polymerase chain reaction [qPCR] assay); and 2) alanine transaminase (ALT) level normal.
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up
Time frame: Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)
The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as <100 copies/mL serum by qPCR assay); and 2) ALT level normal.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PEG-Intron and Interferon Alfa-2B in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
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 22 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 9 Apr 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 9 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Achieving Responder Status at 24 Weeks of Treatment (time frame: Up to 24 weeks). 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?
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 9 Apr 2019.