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Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)

NCT04790916 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-09-18

Study results available
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Summary

The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.

Conditions

  • Autoimmune Hepatitis
  • Autoimmune Chronic Hepatitis

Interventions

DRUG

RO7049665

RO7049665, subcutaneous injection, Q2W.

OTHER

Placebo

RO7049665-matching placebo, subcutaneous injection, Q2W.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2021-11-18
Completion
2021-11-18

Countries

  • Australia
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT04790916 on ClinicalTrials.gov