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NCT01590225
Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
Phase 3 trial testing Boceprevir in Chronic Hepatitis C. Withdrawn.
18 August 2021
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 28 January 2013 |
| Primary completion | 18 August 2021 |
| Estimated completion | 18 August 2021 |
Drugs / interventions tested
- Boceprevir (BOCEPREVIR) — full drug profile →
- Peginterferon alpha-2b — full drug profile →
- Ribavirin — full drug profile →
- Boceprevir (BOCEPREVIR) — full drug profile →
- Peginterferon alfa-2b — full drug profile →
- Ribavirin — full drug profile →
Conditions studied
- Chronic Hepatitis C — all drugs for Chronic Hepatitis C →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
Adults 3 to 17, any sex, with Chronic Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
New prospects for the treatment and prevention of hepatitis C in children.
Ohmer S, Honegger J. · · 2016 · cited 17× · PMID 26709684 · DOI 10.1097/mop.0000000000000313 -
The Role of Direct-acting Antivirals in the Treatment of Children with Chronic Hepatitis C.
Yang CHT, Yoo ER, Ahmed A. · · 2017 · cited 7× · PMID 28507928 · DOI 10.14218/jcth.2016.00053
Verify or expand the search:
- PubMed search for NCT01590225
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Boceprevir
Trials testing the same drug.
- NCT01945294 — Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previous · Phase 3 · completed
- NCT01657552 — Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects · Phase 1 · completed
- NCT01544920 — Safety and Efficacy of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Interleukin-28B CC Allele-Positive Chronic Hepatiti · Phase 3 · completed
- NCT01425190 — Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614) · Phase 1 · terminated
- NCT01425203 — The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160) · Phase 3 · completed
Other recruiting trials for Chronic Hepatitis C
Currently open trials in the same condition.
- NCT06180590 — The Efficacy of Vosevi in Treating DAA-experienced Patients · recruiting
- NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong · active not recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
- NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
- NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
- NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
- NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
- NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01590225 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 29 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01590225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing