Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00805805
• Date of registration: 08/12/2008
• Prospective Registration: No
• Primary sponsor: George Brewer
• Public title: Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis
• Scientific title: Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis
• Date of first enrolment: April 2006
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00805805
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Generally medically healthy

- Age 18 and older

- Documented primary biliary cirrhosis

- Alkaline phosphatase > 137

Exclusion Criteria:

- Severe liver decompensation

- Requirement for renal dialysis

- Pregnancy or nursing

- Meld score > 15 (13-15 will require a physician's clinical judgment)

- Uncontrolled congestive heart failure

- Severe diabetic neuropathy

- Severe pulmonary disease

- Advanced cancer

- Requirement for steroid therapy

- Uncontrolled ascites, variceal hemorrhage or spontaneous bacterial peritonitis

- Pregnant or nursing



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Other: Placebo

Drug: Tetrathiomolybdate

Primary Outcome(s)

Improvement in drug treated group vs placebo group in two liver function tests and one serum cytokine measurement [Time Frame: 2 years]

Secondary Outcome(s)

Improvement in drug treated group vs placebo group in serum CRP or interleukin-1-beta-levels [Time Frame: 2 years]

Secondary ID(s)

PBC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

FDA Office of Orphan Products Development