A Phase 3 interventional study of PegIntron (peginterferon alfa-2b; SCH 54031) and REBETOL (ribavirin; SCH 18908) in Hepatitis, Hepatitis C, Chronic and Fibrosis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 2,333 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) · Drug: REBETOL (ribavirin; SCH 18908)
PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks
Also known as: SCH 54031
REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks
Sustained Virologic Response (SVR) Rate
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
Time frame: Assessed at end of 24 weeks posttreatment follow-up
Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12
Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
Time frame: 24 weeks posttreatment
Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12
Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
Time frame: 24 weeks posttreatment
| Milestone | PegIntron Plus Rebetol |
|---|---|
| Started | 2312 |
| Completed | 928 |
| Not completed | 1384 |
| Withdrew: Adverse event | 165 |
| Withdrew: Lost to follow-up | 18 |
| Withdrew: Protocol violation | 24 |
| Withdrew: Withdrawal by subject | 97 |
| Withdrew: Did not meet eligibility criteria | 11 |
| Withdrew: Administrative | 1 |
| Withdrew: Discontinued at week 12 per protocol | 1061 |
| Withdrew: Never entered follow-up | 7 |
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
| Participants | PegIntron Plus Rebetol |
|---|---|
| Sustained Virologic Response (SVR) Rate | 497 |
Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
| Participants | PegIntron Plus Rebetol |
|---|---|
| Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 | 463 |
Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
| Participants | PegIntron Plus Rebetol |
|---|---|
| Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 | 23 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PegIntron Plus Rebetol | — | 200/2,312 (8.7%) | 2,201/2,312 (95.2%) |
| Event | PegIntron Plus Rebetol |
|---|---|
| PNEUMONIAInfections and infestations | 10/2312 |
| DEPRESSIONPsychiatric disorders | 10/2312 |
| CHEST PAINGeneral disorders | 8/2312 |
| SUICIDAL IDEATIONPsychiatric disorders | 8/2312 |
| NEUTROPENIABlood and lymphatic system disorders | 7/2312 |
| CELLULITISInfections and infestations | 7/2312 |
| APPENDICITISInfections and infestations | 6/2312 |
| ROAD TRAFFIC ACCIDENTInjury, poisoning and procedural complications | 6/2312 |
| HEPATIC NEOPLASM MALIGNANTNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/2312 |
| ANAEMIABlood and lymphatic system disorders | 4/2312 |
| Event | PegIntron Plus Rebetol |
|---|---|
| HEADACHENervous system disorders | 938/2312 |
| PYREXIAGeneral disorders | 900/2312 |
| FATIGUEGeneral disorders | 759/2312 |
| MYALGIAMusculoskeletal and connective tissue disorders | 714/2312 |
| NAUSEAGastrointestinal disorders | 587/2312 |
| INSOMNIAPsychiatric disorders | 519/2312 |
| CHILLSGeneral disorders | 510/2312 |
| ASTHENIAGeneral disorders | 496/2312 |
| INFLUENZA LIKE ILLNESSGeneral disorders | 493/2312 |
| NEUTROPENIABlood and lymphatic system disorders | 455/2312 |
| Age, Categorical(Participants) | PegIntron Plus Rebetol |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2267 |
| >=65 years | 45 |
| Age, Continuous(years) | PegIntron Plus Rebetol |
|---|---|
| Mean | 49.2 ± 8.1 |
| Sex: Female, Male(Participants) | PegIntron Plus Rebetol |
|---|---|
| Female | 662 |
| Male | 1650 |
| Hepatitis C Virus (HCV) Genotype(number of participants) | PegIntron Plus Rebetol |
|---|---|
| Genotype 1 | 1859 |
| Genotype 2 | 75 |
| Genotype 3 | 293 |
| Genotype 4 | 68 |
| Nontypable | 8 |
| Missing | 9 |
| METAVIR Fibrosis score(number of participants) | PegIntron Plus Rebetol |
|---|---|
| F1 | 2 |
| F2 | 658 |
| F3 | 676 |
| F4 | 974 |
| Missing | 2 |
No study locations are listed for this record.
Plan to share: 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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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