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Porphyria clinical trials

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NCT ID: NCT00004789 Completed - Porphyria Clinical Trials

Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria

Start date: July 1993
Phase: Phase 1/Phase 2
Study type: Interventional

OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20 patients with acute attacks of porphyria. II. Evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of acute porphyria in up to 15 patients. III. Estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission. IV. Evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

NCT ID: NCT00004788 Completed - Porphyria Clinical Trials

Study of Nutritional Factors in Porphyria

Start date: May 1988
Phase: N/A
Study type: Observational

OBJECTIVES: I. Determine whether differences in dietary habits are associated with disease activity in patients with acute intermittent porphyria. II. Determine whether premenstrual porphyria attacks are associated with increased luteal phase energy requirements. III. Determine whether energy requirements are higher than intakes in men with unexplained frequent porphyria attacks. IV. Assess the nutritional status of women with acute intermittent porphyria using a comprehensive series of laboratory methods, including zinc and pyridoxine status. V. Determine whether the frequency of disease exacerbations decreases when dietary and nutritional abnormalities are corrected in these patients. VI. Evaluate the safety and efficacy of a parenteral nutrition regimen for patients with acute porphyria attacks.

NCT ID: NCT00004398 Completed - Porphyria Clinical Trials

Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria

Start date: January 1998
Phase: Phase 1
Study type: Interventional

OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate. II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.

NCT ID: NCT00004397 Completed - Porphyria Clinical Trials

Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria

Start date: January 1998
Phase: Phase 1
Study type: Interventional

OBJECTIVES: I. Evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme infusions needed to prevent acute attacks of porphyria. II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.

NCT ID: NCT00004396 Completed - Porphyria Clinical Trials

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

Start date: September 1997
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria. II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.

NCT ID: NCT00004331 Recruiting - Porphyria Clinical Trials

Studies in Porphyria I: Characterization of Enzyme Defects

Start date: November 1992
Phase: N/A
Study type: Observational

OBJECTIVES: I. Characterize enzyme defects in patients with known or suspected porphyria and their family members. II. Determine whether selected patients are eligible for other porphyria research protocols. III. Provide blood, urine, and fecal samples from well characterized patients and their family members to investigators studying the nature of specific mutations in genes for heme biosynthetic pathway enzymes.

NCT ID: NCT00004330 Completed - Porphyria Clinical Trials

Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks

Start date: March 1987
Phase: N/A
Study type: Interventional

OBJECTIVES: Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women.