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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Valme University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Seville
Information provided by:
Valme University Hospital
ClinicalTrials.gov Identifier:
NCT00856804
First received: March 3, 2009
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
Hepatitis C
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II

Resource links provided by NLM:


Further study details as provided by Valme University Hospital:

Primary Outcome Measures:
  • Virological response at week 12 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sustained virological response 24 weeks after the end of therapy [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Safety of using thalidomide together with SOC. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: March 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: thalidomide adding to peginterferon + ribavirin

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856804

Contacts
Contact: Manuel Romero-Gomez, M.D.Ph.D +34 955 015761 mromerogomez@us.es

Locations
Spain
Hospital de Valme Recruiting
Sevilla, Spain, 41014
Contact: Manuel Romero-Gomez, M.D. Ph.D    +34 955015761    mromerogomez@us.es   
Sponsors and Collaborators
Valme University Hospital
University of Seville
Investigators
Principal Investigator: Manuel Romero-Gomez, Prof. Valme University Hospital
  More Information

No publications provided

Responsible Party: Manuel Romero-Gomez, Valme University Hospital
ClinicalTrials.gov Identifier: NCT00856804     History of Changes
Other Study ID Numbers: TRITAL
Study First Received: March 3, 2009
Last Updated: March 5, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Valme University Hospital:
Thalidomide
Hepatitis C
Interferon resistance
Immunomodulators

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014