- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004831
Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria
OBJECTIVES:
I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study.
Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks.
Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up visits at the end of each drug ingestion period.
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Documented erythropoietic protoporphyria Determination of elevated protoporphyrin within the past year Experiencing photosensitivity --Prior/Concurrent Therapy-- No concurrent use of betacarotene --Patient Characteristics-- Other: Not pregnant or nursing Fertile female patients must use effective contraception while on study and for 3 weeks thereafter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Micheline M Mathews-Roth, St. Luke's-Roosevelt Hospital Center
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/13413
- BWH-FDR000996-EF
- SLRH-CU-FDR000996-EF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erythropoietic Protoporphyria
-
University of UtahNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsTerminatedErythropoietic Protoporphyria (EPP) | X Linked Erythropoietic ProtoporphyriaUnited States
-
Mitsubishi Tanabe Pharma America Inc.CompletedErythropoietic Protoporphyria (EPP)United States
-
University of Alabama at BirminghamPorphyria Rare Disease Clinical Research ConsortiumCompletedErythropoietic Protoporphyria (EPP)United States
-
Icahn School of Medicine at Mount SinaiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Rare... and other collaboratorsCompletedErythropoietic Protoporphyria | EPP | XLP | X-Linked Protoporphyria | XLPP | X-Linked Dominant Erythropoietic Protoporphyria | XLEPP | XLDPUnited States
-
Brigham and Women's HospitalCompleted
-
Amy K. Dickey, M.D.Wake Forest University Health Sciences; University of TexasRecruitingErythropoietic Protoporphyria | X-linked ProtoporphyriaUnited States
-
Icahn School of Medicine at Mount SinaiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedErythropoietic Protoporphyria | EPP | X-linked Protoporphyria | XLPUnited States
-
Bispebjerg HospitalRecruitingErythropoietic ProtoporphyriaDenmark
-
Clinuvel Pharmaceuticals LimitedCompletedErythropoietic ProtoporphyriaUnited States
-
Bispebjerg HospitalUnknownErythropoietic ProtoporphyriaDenmark
Clinical Trials on cysteine hydrochloride
-
Brigham and Women's HospitalCompletedErythropoietic Protoporphyria
-
Centre for Addiction and Mental HealthCompleted
-
Louisiana State University Health Sciences Center...CompletedVitamin D DeficiencyUnited States
-
Assiut UniversityNot yet recruiting
-
Mario Negri Institute for Pharmacological ResearchBio3 Research s.r.l. - Milan ItalyCompleted
-
National Institute of Diabetes and Digestive and...CompletedHeart Diseases | Diabetes | Oxidative StressUnited States
-
Universidade Estadual de MaringáUnknownBipolar DisorderBrazil
-
AmgenTerminatedChronic Kidney Disease | Hyperparathyroidism, SecondaryUnited States, Belgium, Italy, Hungary, Czechia, France, Germany, Poland, Netherlands, Russian Federation, New Zealand, Mexico, Slovakia
-
Assiut UniversityNot yet recruiting
-
Ain Shams UniversityRecruiting