Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance

NCT ID: NCT00856804

Last Updated: 2009-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-06-30

Brief Summary

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

Conditions

Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

thalidomide added to peg-interferon + ribavirina

Group Type: EXPERIMENTAL

thalidomide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

thalidomide adding to peginterferon + ribavirin

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: collaborator

Valme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Valme University Hospital

Principal Investigators

Manuel Romero-Gomez, Prof.

Role: PRINCIPAL_INVESTIGATOR

Valme University Hospital

Locations

Hospital de Valme

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Manuel Romero-Gomez, M.D.Ph.D

Role: CONTACT

mromerogomez@us.es

+34 955 015761

Facility Contacts

Manuel Romero-Gomez, M.D. Ph.D

Role: primary

mromerogomez@us.es

+34 955015761

Other Identifiers

TRITAL

Identifier Type: -

Identifier Source: org_study_id