- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004940
Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
OBJECTIVES:
I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE: This is a phase III study, lasting 3 years; 1996-1999. Patients are administered L-cysteine orally twice daily, 2 capsules with breakfast and 2 with lunch.
Patients fill in questionnaires and diary sheets about their reaction to sunlight exposure, and have blood tested 3 times a year.
Completion date provided represents the completion date of the grant per OOPD records
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Erythropoietic protoporphyria RBC protoporphyrin greater than 50 micrograms/100 dL
--Prior/Concurrent Therapy--
At least 3 months since prior betacarotene or L-cysteine
No concurrent betacarotene
--Patient Characteristics--
- Fertile female patients must use effective contraception for duration of trial and for 3 weeks thereafter
- Not pregnant or nursing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Micheline Mary Mathews-Roth, Brigham and Women's Hospital
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
- 199/13376
- BWH-FDR000996-DR
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
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University of UtahNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsTerminatedErythropoietic Protoporphyria (EPP) | X Linked Erythropoietic ProtoporphyriaUnited States
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Mitsubishi Tanabe Pharma America Inc.CompletedErythropoietic Protoporphyria (EPP)United States
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University of Alabama at BirminghamPorphyria Rare Disease Clinical Research ConsortiumCompletedErythropoietic Protoporphyria (EPP)United States
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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
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Mitsubishi Tanabe Pharma America Inc.RecruitingErythropoietic Protoporphyria (EPP) | X-Linked Protoporphyria (XLP)United States, Spain, France, United Kingdom, Japan, Italy, Australia, Bulgaria, Czechia, Netherlands, Poland
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Disc Medicine, IncEnrolling by invitationErythropoietic ProtoporphyriaUnited States, Australia
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Clinuvel Pharmaceuticals LimitedCompletedErythropoietic Protoporphyria
Clinical Trials on cysteine hydrochloride
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FDA Office of Orphan Products DevelopmentSt. Luke's-Roosevelt Hospital CenterCompletedErythropoietic Protoporphyria
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Centre for Addiction and Mental HealthCompleted
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Louisiana State University Health Sciences Center...CompletedVitamin D DeficiencyUnited States
-
Assiut UniversityNot yet recruiting
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Mario Negri Institute for Pharmacological ResearchBio3 Research s.r.l. - Milan ItalyCompleted
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National Institute of Diabetes and Digestive and...CompletedHeart Diseases | Diabetes | Oxidative StressUnited States
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Universidade Estadual de MaringáUnknownBipolar DisorderBrazil
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AmgenTerminatedChronic Kidney Disease | Hyperparathyroidism, SecondaryUnited States, Belgium, Italy, Hungary, Czechia, France, Germany, Poland, Netherlands, Russian Federation, New Zealand, Mexico, Slovakia
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Assiut UniversityNot yet recruiting
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Per HellströmUniversity of Helsinki; CTC Clinical Trial Consultants AB; Biohit Oyj, Helsinki... and other collaboratorsCompleted