A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) in relapsed HCV-1 infected patients

Phase 2

Completed

• Conditions: chronic liver infection; Hepatitis C; 10047438

• Registration Number: NL-OMON33087
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Chronic Hepatitis C Genotype 1
2. HCV-RNA should be * 4 x 105 IU/mL at screening.
3. Recipient of prior long acting interferon (either as PegIntron, Pegasys or albumin-interferon alpha-2b) and ribavirin (either ribavirin or the ribavirin pro-drug, viramidine) treatment for at least 3 months prior to start study (Visit 1), with documented negative serum HCV RNA on treatment , who subsequently becomes serum HCV RNA positive after stopping treatment (*relapser*). Patients must have been off all treatment for at least 3 months.
4. Male and female subjects age 18 to 69 years of age
5. Platelets counts > 150,000

Exclusion Criteria

1. Use of any HCV-specific anti-viral medications within 3 months prior to start study 2. Prior receipt of any investigational anti-HCV therapy that is not interferon or ribavirin
3. Women of child-bearing potential
4. Evidence of cirrhosis at the time of screening
5. Evidence of hepatic decompensation
6. Evidence of current or past HBV or HIV infection
7. History of treatment for depression or mental illness
8. Pregnant or lactating females
9. Inability to limit alcohol consumption * 35 gm/day
10. Current use of illicit drugs
11. Oral or intravenous steroid treatment or immunosuppression 3 months prior to screening or anticipated need for such treatment within the entire study period (72 weeks)
12. History of clinical evidence of chronic cardiac disease or ECG with clinically significant abnormalities
13. Current treatment for hypothyroidism
14. Has any of the following laboratory values at screening
* Hgb <12 g/dL in males or <11 g/dL in females.
* White blood cell count < 3,000/mm3
* Absolute neutrophil count (ANC) < 1,500/mm3
* Platelet count < 150,000 per mm3
* BUN or serum creatinine > ULN (confirmed), or Creatinine clearance < 50 mL/min
* Serum amylase or lipase > 2X ULN
* Fasting triglycerides > ULN
* Patients with total alpha-fetoprotein levels above 500 ng/ml
15. Lenticular opacity, which according to the investigator, will require cataract surgery within 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy:<br /><br>- HCV RNA is being measured at several timepoints. The results of these tests<br /><br>will be kept blinded until the end of the data base lock, for both<br /><br>investigators as patients.<br /><br><br /><br>Safety:<br /><br>- Physical Examination (incl. blood pressure, pulse, temperature and<br /><br>respiratory measurements)<br /><br>- Routine lab/urine<br /><br>- ECG<br /><br>- PTT/INR (blood)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>- eye monitoring<br /><br>- depression scale<br /><br>- pharmacokinetics</p><br>