Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00492700
Other study ID # LIDO-Trials-01
Secondary ID
Status Completed
Phase Phase 2
First received June 26, 2007
Last updated June 26, 2007
Start date January 2003

Study information

Verified date June 2007
Source Association pour la Recherche sur les Maladies Hépatiques Virales
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).


Description:

Phase one : A double blind randomized placebo controlled trial of rosiglitazone

- 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year.

- after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment

Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis

Phase II extension open label trial

All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Histologically proven NASH with steatosis >= 20%

- Increased serum ALT

Exclusion Criteria:

- bland steatosis

- daily alcohol > 20/30 g (women/men)

- any other cause of liver disease

- secondary NASH including drug-induced steatohepatitis

- treatment with insulin or glitazones

- cardiac insufficiency

- Hb < 10 g/dl

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
rosiglitazone


Locations

Country Name City State
France Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière Paris

Sponsors (1)

Lead Sponsor Collaborator
Association pour la Recherche sur les Maladies Hépatiques Virales

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary improvement in steatosis
Secondary improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis
See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Completed NCT04573543 - The Role of Immune Semaphorins in NAFLD
Completed NCT01695083 - Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients
Not yet recruiting NCT05605158 - Comparative Clinical Study Between Empagliflozin Versus Pioglitazone in Non-diabetic Patients With Non-alcoholic Steatohepatitis Phase 3
Completed NCT01761370 - Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH) N/A
Completed NCT03432377 - Coffee Consumption and NASH in the French Population.
Withdrawn NCT03864835 - NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal N/A
Completed NCT05357352 - Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis
Not yet recruiting NCT03803540 - Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis Phase 1
Completed NCT02395900 - The Effects of Flaxseed Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease Phase 2/Phase 3
Completed NCT01791959 - The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis Phase 2/Phase 3
Recruiting NCT05821010 - Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis Phase 2
Recruiting NCT03734510 - The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study N/A
Recruiting NCT02721264 - Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis. N/A
Terminated NCT03883607 - Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) Phase 2
Completed NCT03863574 - Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis Phase 2
Recruiting NCT03377153 - The Effects of Hesperidin and Flaxseed on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease N/A
Recruiting NCT03377140 - The Effects of Hesperidin on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease N/A
Active, not recruiting NCT04669158 - Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis Phase 1/Phase 2
Recruiting NCT06176079 - Hyperpolarized Pyruvate (13C) Magnetic Resonance Imaging In Patients With Fatty Liver Disease