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NCT00097435
A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
Phase 2 trial testing Albuferon in Hepatitis C in 115 participants. Completed in 1 August 2007.
1 August 2007
Quick facts
| Lead sponsor | Human Genome Sciences Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 115 |
| Start date | 1 October 2004 |
| Primary completion | 1 August 2007 |
| Estimated completion | 1 August 2007 |
| Sites | 8 locations across United States |
Drugs / interventions tested
Conditions studied
- Hepatitis C — all drugs for Hepatitis C →
Sponsor
Human Genome Sciences Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
Sponsor's own description
This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00097435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Albuferon
Trials testing the same drug.
- NCT00489385 — An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two · Phase 1 · completed
Other recruiting trials for Hepatitis C
Currently open trials in the same condition.
- NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
- NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
- NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
- NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
- NCT05208697 — Tele-Harm Reduction · NA · active not recruiting
Other Human Genome Sciences Inc. trials
Trials by the same sponsor.
- NCT02016963 — An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection · Phase 2, PHASE3 · completed
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 NCT00097435 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Human Genome Sciences Inc.
- Last refreshed: 1 August 2013
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/NCT00097435.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing