Suspended

A Randomized, Double-Blind, Controlled, Multi-Center Phase 2 Study to Evaluate the Effect of Roflumilast Plus Pioglitazone on Liver Enzymes and Liver Fat Content in Subjects With Nonalcoholic SteatoHepatitis

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What is being tested

Roflumilast

+ Pioglitazone

+ Roflumilast

Drug
Who is being recruted

From 18 to 80 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: February 1, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

This proof of concept study will evaluate the effect of roflumilast and pioglitazone on transaminase levels and liver fat content. Takeda has chosen not to continue this Study, however, randomized subjects were allowed to complete the study per protocol. The decision to terminate the study is not related to any safety concerns with either of the study medications.

NCT01703260
Principal SponsorAstraZeneca
Last updated: February 1, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

13 inclusion criteria required to participate
A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose
A male who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 weeks after last dose
Has a NAFLD Activity Score (NAS) of >= 3, with a score of at least 1 in steatosis and lobular inflammation - the subcomponents of NAS. It is acceptable if the score for hepatocyte ballooning is "zero"
Has a historical diagnosis of NASH, established no more than 12 months prior to study entry based on histology (liver biopsy)
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24 exclusion criteria prevent from participating
Clinically relevant abnormal laboratory values suggesting an undiagnosed disease other than NASH requiring further clinical evaluation (as assessed by the Investigator)
If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period
Subject with a history of bariatric surgery within 5 years prior to Screening
Subject with a history of weight loss or weight gain of > 10 pounds within 6 months prior to Screening
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Roflumilast dose and pioglitazone dose, orally for up to 4 months

Group II

Experimental
Roflumilast dose and pioglitazone matching-placebo dose orally for up to 4 months.

Group III

Experimental
Pioglitazone dose, orally and roflumilast matching-placebo dose, orally for up to 4 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Coronado, United StatesOpen in Google Maps

Coronado, United States

Annapolis, United States

Baltimore, United States
Suspended4 Study Centers