MedDataX Logo

Sorbent Therapy of the Cutaneous Porphyrias

NCT ID: NCT01422915

Last Updated: 2017-04-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators demonstrated that cholestyramine is an effective binding agent in vitro for porphyrins. A few isolated case reports of treatment of individuals with a cutaneous porphyria suggest that cholestyramine and colestipol effectively remove porphyrins. Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria

NCT00004831

Erythropoietic Protoporphyria
COMPLETED NA

Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias

NCT00004396

Porphyria
COMPLETED PHASE2

Studies in Porphyria I: Characterization of Enzyme Defects

NCT00004331

Porphyria
UNKNOWN

Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria

NCT00004940

Erythropoietic Protoporphyria
COMPLETED PHASE3

Vitamin D and Bisphosphonates in the Treatment of Sickle Cell Disease

NCT02972138

Sickle Cells Disease
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Four adults with proven EPP volunteered as subjects for this study. First period: Subjects received 1 gm colestipol twice daily for \~45 days, then 2 gm twice daily for \~45 days. Labs included CBC; liver chemistries including cholesterol; serum iron, TIBC and ferritin; erythrocyte and plasma protoporphyrin concentrations; and completion of sun exposure questionnaire focused on cutaneous manifestations every 2-4 weeks. Second period: Subjects received colestipol tablets, 2 grams twice daily, completing the sun exposure questionnaire and protoporphyrin determinations \~monthly for 5-6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erythropoietic Protoporphyria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

colestipol treatment

2 grams morning and bedtime for 180 days

Group Type EXPERIMENTAL

Colestipol

Intervention Type DRUG

2 grams morning and bedtime for 90 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colestipol

2 grams morning and bedtime for 90 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult over age 21
* healthy

Exclusion Criteria

* Intercurrent illness
* pregnancy
Minimum Eligible Age

22 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Tishler

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010P002253

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda
NCT01573754 COMPLETED PHASE2
Study of the Pathogenesis of Porphyria Cutanea Tarda
NCT00005103 COMPLETED
Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia
NCT01709032 COMPLETED PHASE1/PHASE2
Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria
NCT03682731 COMPLETED
Effect of Oral Cimetidine in the Protoporphyrias
NCT05020184 COMPLETED PHASE2
Decision Aid for Therapeutic Options In Sickle Cell Disease
NCT02326597 COMPLETED NA
Mitoferrin-1 Expression in Erythropoietic Protoporphyria (Porphyria Rare Disease Clinical Research Consortium (RDCRC))
NCT01880983 COMPLETED
Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement
NCT03990181 COMPLETED NA
Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis
NCT01810965 COMPLETED NA
Adherence of Beta Thalssemia Patients to Oral Chelation Therapy
NCT06568926 RECRUITING NA
Inhibitory Effect of a Polyphenol Supplement on Dietary Iron Absorption in Adults with Thalassemia
NCT05326503 COMPLETED NA
Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)
NCT01996683 UNKNOWN NA
Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
NCT06797583 NOT_YET_RECRUITING NA
Phase II Study of Arginine Butyrate With or Without Epoetin Alfa in Patients With Thalassemia Intermedia
NCT00006136 COMPLETED PHASE2
Vascular Function Intervention Trial in Sickle Cell Disease
NCT01718054 UNKNOWN PHASE2/PHASE3
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
NCT02000830 COMPLETED
Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone
NCT00000588 COMPLETED PHASE2
A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet
NCT01430091 COMPLETED PHASE1
Longitudinal Study of the Porphyrias
NCT01561157 RECRUITING
Evidence-based Assessment of Medication Sensitivity in Acute Hepatic Porphyria
NCT03906214 COMPLETED
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
NCT04106258 COMPLETED PHASE4
Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
NCT01363908 TERMINATED PHASE2
L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia
NCT00125788 COMPLETED PHASE2
Study of Beet Juice for Patients With Sickle Cell Anemia
NCT02162225 WITHDRAWN PHASE2
Combination Iron Chelation Therapy
NCT00004982 COMPLETED PHASE1