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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Manuel Romero-Gomez, M.D.Ph.D
  • Phone Number: +34 955 015761
  • Email: mromerogomez@us.es

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Virological response at week 12
Time Frame: 36 months
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Valme University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Seville

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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