Platelet Growth Factor Hits Endpoints in Phase II

Tuesday, December 4, 2007 07:24 AM

GlaxoSmithKline reported positive results from two phase II trials of Promacta -- a non-peptide thrombopoietin receptor agonist (platelet growth factor) which can stimulate the growth and differentiation of bone marrow cells that priduce blood platelets -- for the treatment of chronic hepatitis C-associated thrombocytopenia and chronic Idiopathic thrombocytopenic purpura (ITP). The first study was an international, multicenter, double-blind, randomized, placebo-controlled, dose-ranging study. A total of seventy-four HCV-infected subjects with platelet counts between 20,000 and 70,000/mL were enrolled. The subjects received Promacta (30mg, 50mg, or 75mg daily) or placebo for four weeks (pre-antiviral phase).

The primary endpoint was platelet count increase to greater than or equal to 100,000/mL at week four. The subjects could then initiate antiviral therapy and continue Promacta or placebo for 12 additional weeks (antiviral phase).

The primary endpoint was reached by 75%, 79% and 95% of subjects in the Promacta 30mg, 50mg and 75 mg groups respectively, compared to no platelet elevations in the placebo group (p

A total of 118 subjects with chronic ITP and platelet counts

The primary endpoint was achieved in 28%, 70% and 81% of subjects who received Promacta (30mg, 50mg and 75mg, respectively) compared to 11% of the  placebo group

Phase III trials of Promacta are currently underway.   

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

Already a subscriber?
Log in to your digital subscription.

Purchase the July issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

June

CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

Already a subscriber?
Log in to your digital subscription.

Purchase the June issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs