A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases
Recruiting in Palo Alto (17 mi)
+20 other locations
MG
Overseen byMark Gladwin, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Mark Gladwin
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The proposed study is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel groups study aimed to evaluate the safety, tolerability and the efficacy of riociguat compared with placebo in patients with sickle cell disease (SCD).
Research Team
MG
Mark Gladwin, MD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
Age ≥ 18 years
Sickling disorder (HbSS, HbSC, HbSbeta-thalassemia, HbSD, HbSO-Arab documented by hemoglobin electrophoresis or HPLC fractionation)
Females of reproductive potential (FRP) must have a negative, pre-treatment pregnancy test. Post-menopausal women (defined as no menses for at least 1 year or post-surgical from bilateral oophorectomy) are not required to undergo a pregnancy test.
See 3 more
Treatment Details
Interventions
- Placebo (Other)
- Riociguat (Soluble Guanylate Cyclase Stimulator)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RiociguatExperimental Treatment1 Intervention
Treatment Arm
Group II: PlaceboPlacebo Group1 Intervention
Placebo Arm
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston University Medical CenterBoston, MA
Albert Einstein University/ Montefiore Medical CenterBronx, NY
Virginia Commonwealth University Medical CenterRichmond, VA
UNC Comprehensive Sickle Cell CenterChapel Hill, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Mark Gladwin
Lead Sponsor
Trials
3
Patients Recruited
340+