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Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI Clinical research trials and Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI. Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI clinical trial. Test subjects typically receive the most effective healthcare possible for their Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI  Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI
Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI
For Condition: Mucopolysaccharidosis VI
Status: No longer recruiting
Sponsor(s): BioMarin Pharmaceutical ,
Synopsis: The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose levels of weekly intravenous infusions of recombinant human N-acetylgalacto-samine 4-sulfatase (rhASB) for a minimum of 24 weeks in patients diagnosed with MPS VI.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patient consent - Patient must be five years of age or older - Patient must have documented diagnosis of MPS VI, confirmed at screening by measurable clinical signs and symptoms of MPS VI - Leukocyte ASB enzyme activity level less than 20% of the normal range - Clinical evidence of significant MPS VI disease that provides adequate opportunity to achieve quantitative, short-term therapeutic benefit in three or more of the following parameters: endurance (as measured by a six-minute walk test), forced vital capacity (as measured by spirometry), joint range of motion, urinary glycosaminoglycans, and hepatomegaly. - Ability to perform all protocol tests - Ability to stand independently for six minutes - Sexually active subjects must agree to use an adequate form of contraception Exclusion Criteria: - History of bone marrow transplantation - Pregnant or lactating patient - Use of an investigational drug or device within 30 days prior to study participation. - A medical condition, serious intercurrent illness, or other extenuating circumstances that may significantly decrease study compliance including prescribed follow-up - Known hypersensitivity to rhASB or to components of the study drug - History of cancer (except low grade and fully resolved skin malignancy)
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: ASB-00-01;
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048620
Other Mucopolysaccharidosis Vi Studies:
1. Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI
2. Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI
3. Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients with MPS VI
4. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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Double-Blind,2 Dose Group Study of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients with MPS VI
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