52 week multicenter, randomized, double-blind placebo-controlled trial evaluating the efficacy and safety of SNMC in patients with chronic hepatitis C

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000773-60-LV

Enrollment

400

Registered

2005-01-04

Start date

2004-10-22

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Chronic hepatitis C

Interventions

Trade Name: SNMC (Stronger Neo-Minophagen C) Product Name: SNMC Product Code: SNMC Pharmaceutical Form: Solution for injection INN or Proposed INN: Glycyrrhizin CAS Number: 1407-03-0 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Documented non-response or un-sustained response to prior treatment with IFN-alpha/ribavirin therapy for at least 6 months. It must be documented that at least 80% of the doses were administered during these 6 months. Non-response is defined as positive serum HCV-RNA and abnormal ALT values, with ALT value greater than 1.5 ULN. Contraindication for further interferon alpha therapy. 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Chronic hepatitis B (HbsAg+) Auto-immune hepatitis (IgG greater than 30g/l, or positive anti smooth-muscle, anti-liver and kidney microsomal antibodies, or antinuclear antibodies titer greater than 1:80). Serious concomitant disease, including but not restricted to renal insufficiency, major cardiac disease (in particular arrhythmias), edema, diastolic blood pressure greater than 100 mm Hg, hypertension, significant cardiovascular or pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV, disease requiring immunosuppressive therapy). “Fatty liver” (e.g. greater than 30% steatosis in liver biopsy) .

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to evaluate the safety and efficacy of two dose regimens of SNMC (3x 100ml SNMC per week and 5x 100ml per week) compared to placebo in patients with chronic hepatitis C who have not responded to the standard treatment with IFN-alpha and ribavirin.;Secondary Objective: Secondary objective is to compare the two different dose regimens to determine which is most appropriate for the treatment of these patients.;Primary end point(s): There will be two primary efficacy endpoints in the study: 1). Improvement in HAI score after 52 weeks of treatment. 2). Proportion of patients with at least 50% ALT reduction against ALT before treatment within the 12 weeks double-blind treatment phase.	—

Measure

Time frame

Main Objective: The main objective of the study is to evaluate the safety and efficacy of two dose regimens of SNMC (3x 100ml SNMC per week and 5x 100ml per week) compared to placebo in patients with chronic hepatitis C who have not responded to the standard treatment with IFN-alpha and ribavirin.;Secondary Objective: Secondary objective is to compare the two different dose regimens to determine which is most appropriate for the treatment of these patients.;Primary end point(s): There will be two primary efficacy endpoints in the study: 1). Improvement in HAI score after 52 weeks of treatment. 2). Proportion of patients with at least 50% ALT reduction against ALT before treatment within the 12 weeks double-blind treatment phase.

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Countries

Latvia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026