Trials / Terminated
TerminatedNCT03547154
Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)
A RANDOMIZED PHASE 2/3 TRIAL OF SCH 54031 PEG12000 INTERFERON ALFA-2b (PEG INTRON, SCH 54031) VS. INTRON A (SCH 30500) IN SUBJECTS WITH NEWLY DIAGNOSED CML (PROTOCOL NOS. C/I98-026)
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 344 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to compare the efficacy of polyethylene glycol (PEG; pegylated) interferon alfa-2b (PEG Intron, C98026) versus interferon alfa-2b (Intron® A) in the treatment of participants with newly diagnosed CML.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pegylated interferon alfa-2b | Weekly SC injection of pegylated interferon alfa-2b, 6.0 microg/kg |
| BIOLOGICAL | Interferon alfa-2b | Daily SC injection of interferon alfa-2b, 5 MIU/m\^2 |
Timeline
- Start date
- 1998-10-22
- Primary completion
- 2001-02-20
- Completion
- 2001-02-20
- First posted
- 2018-06-06
- Last updated
- 2019-08-12
- Results posted
- 2019-08-12
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03547154. Inclusion in this directory is not an endorsement.