Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance

NCT00856804 | Unknown Phase 2

• 1 other identifier: TRITAL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Hepatitis C

Keywords

Thalidomide; Hepatitis C; Interferon resistance; Immunomodulators

Outcome Measures

Primary Outcomes (1)

• Virological response at week 12

  36 months

Secondary Outcomes (2)

• Sustained virological response 24 weeks after the end of therapy

  36 months

• Safety of using thalidomide together with SOC.

  36 months

Study Arms (1)

1

EXPERIMENTAL

thalidomide added to peg-interferon + ribavirina

Drug: thalidomide

Interventions

thalidomide 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.

Also known as: thalidomide adding to peginterferon + ribavirin

1

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valme University Hospital: lead
• University of Seville: collaborator

Study Sites (1)

Hospital de Valme

Seville, 41014, Spain

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Thalidomide; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Manuel Romero-Gomez, Prof.

  Valme University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+34 955 015761; mromerogomez@us.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 6, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2012
• Last Updated: March 6, 2009

Record last verified: 2009-03

Locations

ES (1)