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Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

NCT01951326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2020-12-08

Study results available
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Summary

The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Conditions

Interventions

DRUG

RHB-104

95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine

DRUG

Placebo

5 placebo capsules administered orally BID

Sponsors & Collaborators

  • RedHill Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • Ira N Kalfus, MD · RedHill Biopharma

  • David Y. Graham, MD · Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-05-31
Completion
2019-08-31

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Israel
  • New Zealand
  • Poland
  • Serbia
  • Slovakia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951326 on ClinicalTrials.gov