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Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

NCT03009396 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-02-24

Study results available
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Summary

An open label extension to the RHB-104-01 Study.

Conditions

  • Crohn Disease

Interventions

DRUG

RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)

For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks

Sponsors & Collaborators

  • RedHill Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • Ira N Kalfus, MD · RedHill Biopharma Limited

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-18
Primary Completion
2018-11-13
Completion
2019-08-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Israel
  • New Zealand
  • Poland
  • Serbia

Study Locations

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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 NCT03009396 on ClinicalTrials.gov