A Phase 1b, Single Center, Clinical Study to Investigate the Safety and Biological Responses to Baminercept in Patients With Chronic HCV Hepatitis.

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01164384

Enrollment

Unknown

Registered

2010-07-16

Start date

2010-10-31

Completion date

2013-02-28

Last updated

2010-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HCV Hepatitis C

Brief summary

Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression. 10 Patienten, open label, 10 Wochen Therapie. Sequentielles Enrollement der ersten 4 Patienten. * Trial with medicinal product

Interventions

DRUGBaminercept

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Informed consent Age 18-60 years Chronic HCV infection Non responder (to Peg-IFN alpha2/Ribavirin containing therapy) Elevated ALT Liver biopsy at screening without sings of (pre-)cirrhosis Compensated liver function Absolute neutrophil count \> 1500 / mm3 at screening Hemoglobin \> 10 g/dL at screening Calculated creatinine clearance of \> 60 cc/min at screening Normal TSH at screening

Exclusion criteria

HBV infection Evidence for concomitant liver disease other than HCV hepatitis Evidence for a HCC Alpha-fetoprotein \>20ng/ml Autoimmune Disease ANA \> 1/320, documented in the last 6 months HIV 1/2 infection ALT and AST \>3x ULN, alkaline phosphatase \>2,5x ULN Known hypersensitivity or allergy to Baminercept Other clinically significant concomitant disease states Known or suspected non-compliance to study protocol, drug or alcohol abuse Infections other than HCV hepatitis Clinically important chest x-ray abnormality at screening Body mass index (BMI) \> 30kg/m2 Concomitant systemic immunosuppressive/-modulating therapy Treatment with anticoagulants Receipt of live vaccine within 4 weeks prior to study start Symptomatic hypogammaglobulinemia with history of recurrent infections Subjects with a history of malignant disease Treatment with other investigational products or participation in an interventional clinical trial within the last 3 months Pregnancy or Breastfeeding Inability or refusal to practice a safe contraception

Design outcomes

Primary

Measure	Time frame
Sicherheit	—

Countries

Switzerland

Contacts

Primary Contact01 Studienregister MasterAdmins

+41 (0)44 255 11 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026