Trial Information

Summary: REPAIR Tier 2 - (Retinoids in Emphysema Patients on the Alpha-1-Antitrypsin International Registry)

Status: No longer recruiting

Protocol Number: NA17598

Sponsor: Hoffmann-La Roche Ltd/Inc/AG/Roche Global Development

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of RAR Gamma on lung function in patients with symptomatic emphysema secondary to alpha-1 antitrypsin deficiency

Brief Summary: This is a placebo-controlled trial to investigate the efficacy, safety, and tolerability of 5mg RAR Gamma administered once daily in patients with symptomatic emphysema secondary to alpha-1 antitrypsin deficiency. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Target sample size is 300.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Placebo
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Emphysema

Intervention Type: Drug

Intervention Name: RAR Gamma

Primary Outcome: 1. Efficacy: Change from baseline in lung density adjusted for lung volume

Key Secondary Outcomes: 1. Efficacy: Spirometry, arterial blood gas, gas transfer, TLco, lung volume, exercise test, dyspnea index, QoL, plasma biomarkers Safety: Adverse events, skin effects, serum lipids, liver enzymes, psychiatric effects, and other retinoid side effects

Inclusion Criteria:

  • men >=30 years of age;
  • women >=30 years of age, and beyond child-bearing potential;
  • non-smokers with a clinical diagnosis of emphysema secondary to alpha-1-antitrypsin deficient emphysema;
  • no oral corticosteroids for >60 days before study.

Exclusion Criteria:

  • concomitant Prolastin replacement therapy;
  • treatment with oral corticosteroids or antibiotics for pulmonary symptoms >3 times in 12 months before study;
  • current use of any CYP 450 3A4 inhibitors or inducers.

Gender: Males or Females

Age Limits: Min: 30 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2003

Trial Registration Date: 07/26/2005

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Marburg, Germany, 35043
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 1:43:13 PM


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