A Multicenter, Open-Label, Pilot Study to Explore the Safety and Efficacy of Intravenous Bortezomib in Patients with Hepatitis C - ViroLogik CT-02

• Conditions: repeated dose treatment with Bortezomib in patients with chronic HCV infection; MedDRA version: 9.1Level: LLTClassification code 10002724Term: Anti-HCV positive

• Registration Number: EUCTR2008-000495-24-DE
• Lead Sponsor: ViroLogik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-28
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Male and females aged <18 years
2. CD4-counts > 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

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 <80mL/min (acc. to the Cockcroft & Gault formula) at Screening
8. Hepatic dysfunction defined as follows:
Alanine aminotransferase (AL(A)T) and aspartate aminotransferase
AS(A)T) >3 x upper limit of the normal range (ULN)
Total bilirubin >1.5mg/dL
9. Abnormal haematologic function (absolute neutrophil count (ANC) <2000/mm3; platelets <150,000/mm3 [±15%] or haemoglobin <12.0g/dL)
10. Low blood pressure (< 110 mm Hg systolic blood pressure) and patients with history of syncope
11. Patients receiving ongoing therapy, or therapy within 7 days of study enrolment, with any of the drugs outlined in Section 6.7
12. Pregnant women or women who are breast-feeding
13. Positive drug test before administration of study medication for the following: cocaine, amphetamines, opiates, ethanol > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified