NCT01157975

Brief Summary

Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems. PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

5.3 years

First QC Date

July 6, 2010

Last Update Submit

November 27, 2019

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • HCV RNA

    Only in the Pioglitazone group

    2 weeks

Secondary Outcomes (3)

  • HCV RNA

    Day 4

  • Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines.

    Day 14 (Pioglitazone) and Day 4 (Prednisone)

  • ALT and AST

    Day 14 (Pioglitazone) and Day 4 (Prednisone)

Study Arms (2)

Pioglitazone

EXPERIMENTAL
Drug: Pioglitazone

Prednisone

EXPERIMENTAL
Drug: Prednisone

Interventions

PioglitazoneDRUG

Pioglitazone will be taken at a dose of 30 mg for up to 14 days

Also known as: ACTOS
Pioglitazone
PrednisoneDRUG

Prednisone will be taken at a dose of 40 mg for up to 4 days

Prednisone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Infection with HCV genotype 1 or 4 (subjects infected with multiple genotypes are not eligible)
  • BMI greater than 25 Kg/m2
  • HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending more than 3 months prior to enrollment for not longer than 2 weeks
  • Plasma HCV RNA concentration of \>10,000 IU/mL at the screening evaluation

You may not qualify if:

  • Previous intolerance to Pioglitazone, Rosiglitazone, Troglitazone or corticosteroids
  • Women who are pregnant or breastfeeding
  • History of diabetes mellitus requiring treatment other than diet
  • Decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency
  • Concurrent hepatitis B virus (HBV) infection
  • Known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease
  • Abuse of alcohol or illicit drugs within 6 months before enrollment
  • Use of an investigational drug within 4 weeks before the screening visit or during the screening period.
  • Use of systemic immunosuppressants
  • History of poorly controlled psychiatric disease or poorly controlled pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California at San Diego Hospitals

San Diego, California, 92037, United States

Location

Agouza Hospital

Giza, Egypt

Location

Related Publications (1)

  • Chojkier M, Elkhayat H, Sabry D, Donohue M, Buck M. Pioglitazone decreases hepatitis C viral load in overweight, treatment naive, genotype 4 infected-patients: a pilot study. PLoS One. 2012;7(3):e31516. doi: 10.1371/journal.pone.0031516. Epub 2012 Mar 7.

    PMID: 22412837DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

PioglitazonePrednisone

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mario Chojkier, MD

    UCSD

    PRINCIPAL INVESTIGATOR

  • Martina Buck, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

  • Hesham Elkhayat, MD

    Cairo University, Egypt

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 8, 2010

Study Start

October 1, 2008

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

EG(1)US(1)