Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis (CAMEO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Lumena Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Lumena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02061540
First received: February 11, 2014
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.


Condition Intervention Phase
Primary Sclerosing Cholangitis (PSC)
Drug: LUM001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Sclerosing Cholangitis

Resource links provided by NLM:


Further study details as provided by Lumena Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, changes in vital signs, laboratory and other safety parameters from baseline to week 14


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Changes in serum bile acids, pruritus, and other biochemical markers of cholestasis and liver disease from baseline to week 14


Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LUM001
LUM001 administered orally once each day
Drug: LUM001

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Primary Sclerosing Cholangitis
  2. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures

Exclusion Criteria:

  1. History or presence of other concomitant significant liver disease
  2. Liver transplant
  3. Known HIV infection
  4. Women who are pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061540

Contacts
Contact: Dee Wynne 858-461-0694 info@lumenapharma.com

Locations
United States, California
University of California at Davis Recruiting
Sacramento, California, United States, 95817
Contact: Sandeep Dhaliwal    916-734-8985    sandeep.dhaliwal@ucdmc.ucdavis.edu   
Principal Investigator: Christopher Bowlus, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Lia Quezada    305-243-6968    LQuezada@med.miami.edu   
Principal Investigator: Cynthia Levy, MD         
Sponsors and Collaborators
Lumena Pharmaceuticals, Inc.
Investigators
Study Director: Alejandro Dorenbaum, MD Lumena Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Lumena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02061540     History of Changes
Other Study ID Numbers: LUM001-401
Study First Received: February 11, 2014
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014