repeated dose treatment with Bortezomib in patients with chronic HCV infection MedDRA version: 9.1 Level: LLT Classification code 10002724 Term: Anti-HCV positive
Conditions
Interventions
Trade Name: VELCADE
Product Name: Bortezomib
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Bortezomib
CAS Number: 179324-69-7
Concentration unit: mg/ml milligram(s)/mil
Sponsors
ViroLogik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and females aged 250/µl 3. Documented laboratory diagnosis of HCV infection with detectable viral load 4. Not tolerating or responding to hepatitis C treatment with interferon and ribavirin 5. No treatment with a HCV active antiviral therapy such as ribavirin and/or interferon =28 days before Baseline 6. Serum HCV ribonucleic acid (RNA) levels > 100 000 copies/mL 7. Patients without relevant uncontrolled infections and in good general health 8. Patients without clinically significant abnormalities at physical examination, vital signs, ECG and laboratory parameters, which may in the judgment of the Investigator/principal Investigator, interfere with the safety of the patient or confound the objectives of the study 9. Normal renal function defined as renal clearance >= 80 mL/min (according to Cockroft & Gault formula at Screening) 10. Negative urine pregnancy test (females of childbearing potential only) 11. Women who are post-menopausal (natural menopause established in retrospect after 12 consecutive months of amenorrhoea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomised partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above 12. Willingness to use highly effective contraception (double barrier method) by both males and females while on study treatment and for 3 months following Bortezomib treatment 13. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 14. Liver biopsy at any time prior to enrollment with a pathology report confirming the histological diagnosis consistent with chronic hepatitis 15. HIV test performed at screening day with negative result Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a familiar history of, a known hypersensitivity or multiple allergies toward drugs, especially hypersensitivity to Bortezomib, boron or mannitol 2. Uncontrolled infection or any chronic infection which requires acute treatment 3. Patients with clinically significant gastrointestinal, renal, hepatic, respiratory, cardiovascular, metabolic or hormonal disorders 4. Patient having experienced cerebral seizures in the past 5. Active or past abnormal function of peripheral nervous system (polyneuropathy) 6. Patients with a present condition, which may alter the pharmacokinetics of a drug, including but not limited to blockers and inducers of cytochrome P450 3A and 2C19 such as HIV 1 PIs, HIV-1 NNRTIs, rifampicin or carbamazepin. 7. Renal dysfunction defined as creatinine clearance 3 x upper limit of the normal range (ULN) Total bilirubin >1.5mg/dL 9. Abnormal haematologic function (absolute neutrophil count (ANC) 0.5 pro mille 14. Current alcohol or substance abuse judged by the Investigator to potentially interfere with patient compliance 15. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements 16. CD4 counts = 250/µL 17. Participation in a study of an investigational drug or device concomitantly or within 30 days prior to this study 18. Patients thought to be unreliable or incapable of complying with the requirements of the protocol 19. Patient is relative of, or staff directly reporting to the investigator 20. Patient is employee of the sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the safety and tolerability of Bortezomib in patients with HCV infection.;Secondary Objective: • To obtain preliminary efficacy data of Bortezomib in patients with chronic HCV infection. • To obtain data regarding progression of HCV related liver diseases by Bortezomib in patients with HCV infection. ;Primary end point(s): Viral load of Hepatitis C | — |
Countries
Germany
Outcome results
None listed