Status:
COMPLETED
Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients
Lead Sponsor:
VGX Pharmaceuticals, LLC
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Hepatitis C virus (HCV) infects approximately 170 million people worldwide. The current standard- of- care therapy of chronic HCV infection is a regimen of subcutaneously administered (pegylated)-inte...
Detailed Description
The 341-nucleotide 5' non-translated region is the most conserved part of the hepatitis C virus (HCV) genome. It contains a highly structured internal ribosomal entry site (IRES) that mediates cap-ind...
Eligibility Criteria
Inclusion
- Hepatitis C infection for ≥ 1 year. Viral load at entry will be measured by the Amplicor Hepatitis C Virus Test Version 2.0 (Roche Molecular Systems; Plesasanton, CA) and genotyped by Trugene HCV 5'NC Genotyping kit (Visible Genetics; Toronto, Canada) performed within 90 days prior to study entry by a lab(s) certified for the assays.
- Male or female ages 18-65 years, inclusive.
- Plasma hepatitis C RNA of \>105 copies/mL (or equivalent international units)
- Laboratory values: stable hepatic, renal, and hematological indices obtained within 30 days prior to study entry, as follows:
- Absolute neutrophil count (ANC) \>= 750/mm³
- Hemoglobin \>= 10.0 g/dL
- Platelet count \>= 100,000/mm3
- Creatinine \<= 2 x ULN
- AST (SGOT), ALT (SGPT), and alkaline phosphatase \<= 3 x ULN
- Total bilirubin \<= 3 x ULN
- Albumin \>= 3 g/dL
- Normal PT and PTT
- Serum lipase \<= 1.5 x ULN
- TSH within normal limits (0.5-6.0 mIU/L)
- Morning plasma cortisol \>= 20 µg/dL
- Normal fasting glucose
- Urinalysis free of clinically significant abnormalities NOTE: Fasting is defined as no oral intake except water for at least 8 hours prior to the study visit.
- Female subjects of reproductive potential (girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months or have not undergone surgical sterilization \[e.g., hysterectomy, bilateral oophorectomy, or salpingotomy\]) must have a negative spot urine pregnancy test result (with a sensitivity of at least 50 mIU/mL) performed at entry, before initiating study medication.
- All subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, or in vitro fertilization). If participating in sexual activity that could lead to pregnancy, the subject/partner must agree to use two reliable methods of contraception simultaneously (condoms with a spermicidal agent; or a diaphragm or cervical cap with spermicide) while on study drug and for 30 days after stopping the medication.
- Female subjects, who are not of reproductive potential, are eligible without requiring the use of contraception. Male subjects must use a condom with every sexual act that could lead to pregnancy.
- NOTE: Acceptable documentation of sterilization is either written or oral documentation communicated by clinician or clinician's staff of one of the following: physician report/letter: operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy); discharge summary; laboratory report of azoospermia; or FSH measurement elevated into the menopausal range as established by the reporting laboratory.
- Karnofsky performance score \>= 80 within 30 days prior to study entry.
- Ability and willingness of subject to give written informed consent.
- Willingness to return for a follow-up visit on day 56.
- Subjects taking any precautionary concomitant medications (see section 5.2.2) must be on stable doses for \>8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study.
Exclusion
- Receipt of anti-hepatitis C therapy within the 4 weeks prior to study entry or intent to initiate ant-hepatitis C therapy within 60 days after entry.
- Clinical evidence of cirrhosis or decompensated liver failure.
- Chronic or acute adrenal failure, history of active hepatitis B, HIV-1 infection, porphyrias, known moderate to severe cirrhosis, hemorrhagic disorders, concurrent anticoagulant therapy, any prior pituitary tumor, surgery, radiation treatment, or pituitary failure.
- Diabetes requiring treatment with oral hypoglycemics or insulin therapy.
- Pregnancy within 90 days prior to study entry.
- Breast-feeding.
- Dysfunctional uterine bleeding within the 12 months prior to study entry.
- Any current hormonal contraception or IUD use.
- Use of drugs that are inhibitors or inducers of metabolism by the CYP 3A4 within 7 days of study entry.
- Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry.
- Use of any cytotoxic chemotherapy, immunomodulators or investigational therapy within 90 days prior to study entry.
- Any vaccination within 30 days prior to study entry.
- Allergy to mifepristone or its formulation.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirement.
- Weight \< 40 kg.
- Any other condition thought by the investigator that may interfere with the patient's ability to comply with the study protocol.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00255177
Start Date
November 1 2005
End Date
January 1 2008
Last Update
November 3 2009
Active Locations (4)
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1
University of Connecticut
Farmington, Connecticut, United States, 06030
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
Saint Louis University
St Louis, Missouri, United States, 63104
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104