Phase 2
Completed N=37
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
Source: ClinicalTrials.gov NCT00812331 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels — -2.02; 0.16; -3.43; -2.71 log10 IU/mL
Summary
The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels |
-2.02; 0.16; -3.43; -2.71; -3.57; -2.46 | — |
| SECONDARY Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period |
3; 0; 8; 6; 8; 3 | — |
| SECONDARY Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period |
0; 1; 2; 3; 0 | — |
| SECONDARY Predose Plasma Concentration (C0h) of TMC435 |
3720; 1310; 6270; 4650; 5440 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) of TMC435 |
3320; 1110; 5450; 4230; 4960 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of TMC435 |
11250; 6580; 13500; 13600; 14800 | — |
| SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435 |
4.01; 6.025; 6.04; 6.00; 6.00 | — |
| SECONDARY Average Steady-State Plasma Concentration (Css,av) of TMC435 |
7115; 3081; 8843; 7850; 9354 | — |
| SECONDARY Fluctuation Index (FI) of TMC435 |
130.2; 149.4; 95.38; 93.12; 88.16 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435 |
170100; 74670; 212000; 189000; 227100 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435 |
268000; 111500; 365500; 360000; 411100 | — |
| SECONDARY Elimination Rate Constant of TMC435 |
0.05042; 0.06024; 0.04308; 0.03826; 0.03784 | — |
| SECONDARY Terminal Elimination Half-life (t1/2,Term) of TMC435 |
13.75; 11.51; 16.09; 18.12; 18.32 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
- Participants who have never received treatment for their HCV infection
- Participants with either no cirrhosis or up to Child Pugh A liver disease
- Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening
Exclusion Criteria
- Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
- Participants with diagnosed or suspected hepatocellular carcinoma
- Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
- Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening
Data sourced from ClinicalTrials.gov (NCT00812331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.