Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance (TRITAL)

March 5, 2009 updated by: Valme University Hospital

Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II

INDICATION:

Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for hepatitis C.

OBJECTIVES:

  1. ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with peginterferon + ribavirin resistance.
  2. To know the response rate in 12 weeks
  3. Describe the tolerance and safety of thalidomide in combination with peginterferon and ribavirin.

DESIGN OF TEST Pilot Study:

The single arm study will:

1. Thalidomide 200 mg and peg-interferon alfa 2b (based on weight: 50-120 mcg / week) + ribavirin (based on weight: 1000-1200mg / day)

Be tracked for 24 weeks after treatment.

Suspended treatment of 12 weeks in patients who have failed a drop of HCV RNA> 2 log.

Patients who have been suspended for any reason, the treatment will be followed during 24 weeks, to assess safety parameters.

SUBJECT NUMBER: 10

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41014
        • Recruiting
        • Hospital De Valme
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women in non fertile age.
  • HCV RNA detectable in serum.
  • Chronic hepatitis C virus with non-cirrhotic compensated liver disease (clinical classification according to Child-Pugh Grade A) (Appendix 1).
  • Genotype 1.
  • Not responding to treatment with peginterferon alfa-2a in combination with Ribavirin.
  • Effective contraceptive measures during treatment and for 6 months after treatment.

Exclusion Criteria:

Patients with any of the following will not be selected for treatment:

  • Patients with liver biopsy compatible with cirrhosis F4 Metav classification.
  • Patients diagnosed with diabetes or basal glycemia higher than 126 mg / dl
  • Women and men of childbearing age
  • Treatment with systemic antineoplastic or immunomodulatory (including suprafisiológicas doses of steroids and radiotherapy) 6 months before the first dose of treatment.
  • Treatment with any investigational drug 6 weeks before the first dose of treatment.
  • History or other evidence of any pathology associated with chronic liver disease than HCV.
  • Signs or symptoms of hepatocellular carcinoma.
  • History or other evidence of bleeding due to esophageal varices or other conditions consistent with decompensated liver disease.
  • neutrophil count <1500 células/mm3 or platelet count <90,000 células/mm3 at Screening.
  • Hb <12 g / dL in women or <13 g / dL in men, at the time of evaluation.
  • Patients with baseline increased risk of anemia (eg thalassemia, spherocytosis, history of gastrointestinal bleeding, etc.). Or where the presence of anemia would be a medical problem.
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be treated if in the opinion of the investigator, could not tolerate an adequately sharp decline in hemoglobin.
  • serum creatinine> 1.5 times above the normal upper limit at the time of valuation.
  • History of severe psychiatric illness, particularly depression. Is defined as a serious psychiatric illness requiring treatment with antidepressants or major tranquilizers in therapeutic doses required for major depression or psychosis, respectively, for at least 3 months at any time before or any of the following background: attempted suicide, hospitalization due to of psychiatric illness, or period of disability due to psychiatric illness.
  • History of seizure disorder or current use of major anticonvulsants.
  • History of immune disease, chronic lung disease associated with limited functionality, serious heart disease, congestive heart failure, advanced atherosclerosis, increased organ transplant or other signs of serious disease, neoplasia, or any other condition deemed by the investigator, prevent the patient is suitable for the study.
  • A history of thyroid disease poorly controlled with medications prescribed, elevated concentrations of thyroid stimulating hormone (TSH) with increased thyroid peroxidase antibodies and any clinical manifestation of thyroid disease.
  • Pathology involving a risk of acute renal function: dehydration (diarrhea, vomiting), fever, infectious states and / or hypotonic severe (shock, sepsis, urinary infection, neuropathy).
  • Evidence of severe retinopathy (eg CMV retinitis, macular degeneration).
  • Exploration programanada radiation with intravenous administration of contrast media (IVU, angiography).
  • Evidence of drug use in the year prior to study.
  • Consumption of alcohol.
  • Inability or unwillingness to give informed consent or to comply with the requirements of the study.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
thalidomide added to peg-interferon + ribavirina
Drug: thalidomide
Open-label pilot study analyzing the impact of adding thalidomide (200 mg/d)to SOC on 12 weeks virological response in patients with chronic hepatitis C and interferon resistance.
Other Names:
  • thalidomide adding to peginterferon + ribavirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Virological response at week 12
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response 24 weeks after the end of therapy
Time Frame: 36 months
36 months
Safety of using thalidomide together with SOC.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valme University Hospital

Collaborators

University of Seville

Investigators

  • Principal Investigator: Manuel Romero-Gomez, Prof., Valme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2009

Last Update Submitted That Met QC Criteria

March 5, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRITAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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