Hepatitis CPhase 3NCT00686517
Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
A Phase 3 study testing Pegylated interferon alfa-2b and Ribavirin in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. 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?
- Pegylated interferon alfa-2b and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2010
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with acute hepatitis C virus (HCV).
- Normal and Elevated serum alanine transferase (ALT) levels
- Positive serum HCV-RNA.
- Aged between 18 and 65 years.
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion
Who cannot join
- Liver disease unrelated to HCV infection
- Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
- Women with ongoing pregnancy or who are breast feeding
- History of severe psychiatric disease, especially depression
- History of neurologic disease, especially epilepsy
- History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
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- Positive anti-Human Immunodeficiency Virus (HIV) antibodies
- Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80)
- Positive Hepatitis B surface antigen (HBsAg)
- History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
- History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)
About this study
Official title: An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C
The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.
- Conditions
- Hepatitis C
- Being tested
- Pegylated interferon alfa-2b, Ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa-2bBiological
Also called SCH 54031, PegIntron
1.5 ug/kg/week SC for 12 or 24 weeks
RibavirinDrug
Also called SCH 18908, Rebetol
Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN 24 | Experimental | pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks Receives: Biological: Pegylated interferon alfa-2b |
| PEG-IFN 12 | Experimental | pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks Receives: Biological: Pegylated interferon alfa-2b |
| PEG-IFN + RVB 12 | Experimental | pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks Receives: Biological: Pegylated interferon alfa-2b; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
Measured: Evaluated at the end of 6 months
Secondary outcomes (5)
Virologic Response at the End of Treatment Follow-up (ETR)
ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks
treatment (depending on treatment arm) was <15 IU/mL.
Measured: At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.
Measured: At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.
Measured: Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.
Number of Participants With Rapid Virologic Response (RVR)
Participants were considered to have RVR if serum HCV RNA level at 2 or 4
weeks of treatment was below the cut off value of the referring local
laboratory of each participating site.
Measured: Evaluated at 2 and 4 weeks of treatment
Number of Peripheral Blood Mononuclear Cells (PBMCs)
Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.
Measured: Treatment Weeks 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startDec 2003
- Primary completionDec 2010
- Study completionDec 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioikos Ambiente Srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686517
- Sponsor's protocol ID
- P03552
- Status last verified
- Mar 2017
- First submitted
- 27 May 2008
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, Angarano G; Acute Hepatitis C Study Group. Acute hepatitis C: a 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. Hepatology. 2014 Jun;59(6):2101-9. doi: 10.1002/hep.26991. Epub 2014 Apr 29.
PubMed 24442928
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C
- ClinicalTrials.gov ID
- NCT00686517
- Acronym / sponsor ID
- P03552
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bioikos Ambiente Srl
- Study start
- Dec 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 31 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN 24 | Experimental | Biological: Pegylated interferon alfa-2bpegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks |
| PEG-IFN 12 | Experimental | Biological: Pegylated interferon alfa-2bpegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks |
| PEG-IFN + RVB 12 | Experimental | Biological: Pegylated interferon alfa-2b, Drug: Ribavirinpegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with acute hepatitis C virus (HCV).
- Normal and Elevated serum alanine transferase (ALT) levels
- Positive serum HCV-RNA.
- Aged between 18 and 65 years.
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion
Key exclusion criteria (11 listed)
- Liver disease unrelated to HCV infection
- Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
- Women with ongoing pregnancy or who are breast feeding
- History of severe psychiatric disease, especially depression
- History of neurologic disease, especially epilepsy
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 |
|---|---|---|
| Pegylated interferon alfa-2bAlso: SCH 54031, PegIntron1.5 ug/kg/week SC for 12 or 24 weeks | Biological | PEG-IFN + RVB 12, PEG-IFN 12, PEG-IFN 24 |
| RibavirinAlso: SCH 18908, RebetolRibavirin at the dose of 10.6 mg/kg/day for 12 weeks | Drug | PEG-IFN + RVB 12 |
Primary outcome
Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
Time frame: Evaluated at the end of 6 months
SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
5 secondary outcomes
Virologic Response at the End of Treatment Follow-up (ETR)
Time frame: At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
Time frame: At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
Time frame: Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.
Number of Participants With Rapid Virologic Response (RVR)
Time frame: Evaluated at 2 and 4 weeks of treatment
Number of Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Treatment Weeks 2, 4, 8, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24442928Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, Angarano G; Acute Hepatitis C Study Group. Acute hepatitis C: a 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. Hepatology. 2014 Jun;59(6):2101-9. doi: 10.1002/hep.26991. Epub 2014 Apr 29.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated interferon alfa-2b and Ribavirin 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 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 5 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2012). 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 With Sustained Response (SR) at the End of the 6-month Follow-up Period (time frame: Evaluated at the end of 6 months). 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 NCT00686517, 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 5 Apr 2017.