Chronic Hepatitis CPhase 2NCT01724086
A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus
A Phase 2 study testing TMC647055, TMC435 and Ritonavir in people with Chronic Hepatitis C, run by Janssen R&D Ireland at 10 sites in 2 countries.
Trial summary
The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and low-dose ritonavir, administered together with and without ribavirin and of TMC647055, TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a limited number of patients with chronic hepatitis C… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- TMC647055, TMC435 and Ritonavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented chronic genotype 1a or genotype 1b hepatitis C virus (HCV) infection with HCV ribonucleic acid (RNA) level >100,000 IU/mL at screening
- Treatment-naive or documented prior relapser to previous treatment regimens and has stopped treatment at least 3 months before screening
- Liver biopsy within 3 years before the screening visit or elastography results available prior to first study drug dosing
- Medically stable based on physical examination, medical history, vital signs, and electrocardiogram performed at screening
- Body mass index of 18.0 to 32.0 kg/m2 and body weight more than 50 kg
Who cannot join
- Evidence of liver cirrhosis by liver biopsy or the presence of esophageal varices or a transient elastography result of >14.6 kPa within 2 years prior to first dosing
- Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices
- Evidence of any significant liver disease in addition to hepatitis C (including but not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis)
- Receiving or has received any HCV-specific direct antiviral agent (HCV protease inhibitors, HCV nucleoside polymerase inhibitors, HCV non-nucleoside polymerase inhibitors, HCV NS5a inhibitors or any other HCV inhibitor targeting an HCV protein or a target involved in the HCV replication cycle
- Co-infected with human immunovirus (HIV)-1 or HIV-2, with non-genotype 1a/1b HCV, or hepatitis A or B virus infection
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Belgium7 sites
Study site
Antwerp
Study site
Bruges
Study site
Brussels
Study site
Edegem
Study site
Ghent
Study site
Leuven
Study site
Liège
About this study
Official title: A Phase IIa, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of a 12 Weeks Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Chronic Genotype 1 Hepatitis C Infected Patients
The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and low-dose ritonavir, administered together with and without ribavirin and of TMC647055, TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a limited number of patients with chronic hepatitis C virus (HCV) infection.
Read the detailed description
This study is an open-label study (all people know the identity of the intervention) in patients who are chronically infected with hepatitis C virus (HCV) genotype-1a (GT1a) or genotype-1b (GT1b) to assess the safety, tolerability and efficacy of the coadministration of TMC647055, TMC435 and low-dose ritonavir (RTV), with and without ribavirin (RBV) and of TMC647055, TMC435, RTV administered together with GSK233680k without RBV for 12 weeks. Approximately 86 patients will be enrolled in this study. Patients enrolled in the study will be chronically infected with HCV of GT1a (n=10) or GT1b (n=20), either treatment-naive patients (ie, patients never having received PegIFN [Pegylated interferon alpha-2a at 180 mcg subcutaneous once a week], RBV, or any other approved or investigational treatment for chronic HCV infection) or patients who are relapsers to prior treatment with PegIFN /RBV (ie, "relapsers" are patients with HCV ribonucleic acid [RNA] undetectable at the last on treatment measurement of a prior PegIFN based regimen of at least 24 weeks, but HCV RNA detectable within 1 year after the last medication intake). Patients in this first part of the study will be divided over 4 panels: Panel 1 will consist of 10 chronic HCV GT1a infected treatment-naive patients/prior relapsers who will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose ritonavir and ribavirin. Panel 2 will consist of 20 chronic HCV GT1b infected treatment-naive patients/ prior relapsers who will be randomly allocated to 2 arms in a 1:1 ratio. Arm 1 (N=10) will receive TMC435 + TMC647055 + low-dose ritonavir and ribavirin. Arm 2 (N=10) will receive TMC435 + TMC647055 + low-dose ritonavir. Panel 3 will consist of 16 chronic HCV GT1a or GT1b infected treatment-naïve patients/prior relapsers who will be allocated to 2 arms: 8 HCV GT1a patients in arm 1 and 8 HCV GT1b patients in arm 2. Patients in Arm 1 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV and RBV and patients in Arm 2 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV. Panel 4 will consist of 40 chronic HCV GT1a or GT1b infected treatment-naïve patients/prior relapsers who will be allocated to 2 arms: each arm will consist of 20 patients of which at most 8 patients will be infected with HCV GT1b. Patients will be randomized in 1:1 ratio between the 2 arms whereby randomization will be stratified by genotype. Patients in Arm 1 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805. Patients in Arm 2 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805. The planned duration of the investigational treatment is 12 weeks. Patients in Panels 1, 2, and 3 may receive follow-up treatment with 12 weeks or 36 weeks of PegIFNα + RBV; follow-up treatment principles will not apply to Panel 4 as based on available proof of concept data for such combinations, the need for an additional 12 or 36-week PegIFN/RBV follow-up therapy is expected to be very low when evaluating a 12-week regimen of 3 direct acting antiviral agents for treatment of HCV genotype 1 infections. Safety will be monitored throughout the study
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Chronic hepatitis C-infected patients, TMC647055, TMC435, Ritonavir, Ribavirin, Genotype 1a, Genotype 1b, GSK2336805
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC647055Drug
Also called JNJ-42039556-AMR-G-001
Type=exact number, unit=mg, number=150, form=capsule, route=oral. 3 or 4 capsules of 150 mg will be administered once daily.
TMC435Drug
Type=exact number, unit=mg, number=75, form=capsule, route=oral. 1 capsule of 75 mg will be administered once daily.
RitonavirDrug
Type=exact number, unit=mg, number=30 or 50, form=tablet or solution, route=oral. 0.375 mL or 0.625 ml (80 mg/mL) solution will be administered once daily.
RibavirinDrug
Type=exact number, unit=mg, number=200, form=tablet, route=oral. 5 to 6 (1000 or 1200 mg) tablets will be administered once daily, divided in 2 daily doses. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment 5 or 6 (depending on bodyweight) tablets of ribavirin (equivalent to 200 mg/tablet) per day, divided in 2 daily doses for an additional 12 or 36 weeks.
Pegylated interferon alpha-2a (PegIFN)Drug
Type=exact number, unit=mcg, number=180, form=solution, route=subcutaneous injection. PegIFN 0.5 mL prefilled syringe equivalent to 180 mcg will be administered as a subcutaneous (under the skin) injection as follow-up (FU) treatment for 12 or 36 weeks based on follow-up treatment principles as described in the protocol. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment with Pegylated interferon alpha-2a (PegIFN) 0.5 mL prefilled syringe equivalent to 180 mcg administered as a subcutaneous (under the skin) injection for an additional 12 or 36 weeks.
GSK2336805Drug
Type=exact number, unit=mg, number=30 or 60, form=tablet, route=subcutaneous injection. GSK2336805 one or two 30 mg tablet(s) taken orally (by mouth) once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Panel 1 | Experimental | 10 chronic HCV genotype 1a (GT1a) infected treatment-naive patients/prior relapsers who will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose ritonavir and ribavirin. Receives: Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: Ribavirin; Drug: Pegylated interferon alpha-2a (PegIFN) |
| Panel 2 Arm 1 | Experimental | 10 chronic HCV GT1b infected treatment-naive patients/ prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir and ribavirin. Receives: Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: Ribavirin; Drug: Pegylated interferon alpha-2a (PegIFN) |
| Panel 2 Arm 2 | Experimental | 10 chronic HCV GT1b infected treatment-naive patients/ prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir. Receives: Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: Ribavirin; Drug: Pegylated interferon alpha-2a (PegIFN) |
| Panel 3 - Arm 1 | Experimental | 8 chronic HCV GT1a infected treatment naïve patients/prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir + ribavirin. Receives: Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: Ribavirin; Drug: Pegylated interferon alpha-2a (PegIFN) |
| Panel 3 - Arm 2 | Experimental | 8 chronically HCV GT1b infected treatment naïve patients/prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir. Receives: Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: Pegylated interferon alpha-2a (PegIFN) |
| Panel 4 - Arm 1 | Experimental | 20 chronic HCV GT1a or GT1b infected treatment-naive patients/ prior relapsers will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805 (30 mg once daily) Receives: Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: GSK2336805 |
| Panel 4 - Arm 2 | Experimental | 20 chronic HCV GT1a or GT1b infected treatment-naive patients/ prior relapsers will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805 (60 mg once daily) Receives: Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: GSK2336805 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a sustained virologic response (SVR) 12 Weeks after the actual end of treatment
SVR12 is defined as undetectable HCV RNA at the actual end of treatment and HCV RNA less than 25 IU/mL at 12 Weeks after the actual end of treatment.
Measured: Week 24 (Up to 12 weeks after end-of treatment visit)
Number of patients with adverse events
Number of patients with adverse events, serious adverse events, abnormal changes in safety related laboratory values, abnormal changes in vital signs and physical examination, and abnormal echocardiogram.
Measured: Up to Week 48 (24 weeks after end of treatment)
Secondary outcomes (17)
Number of patients with a sustained virological response (SVR at 4 and/or 24 Weeks after the actual end of treatment)
Measured: Up to 24 weeks after end of treatment
HCV RNA levels over time
Measured: Up to 24 weeks after end of treatment
Number of patients with undetectable hepatitis C virus (HCV) RNA (less than 25 IU/mL undetectable) and/or HCV RNA levels less than 25 IU/mL at all time points
Measured: Up to 24 weeks after end of treatment
Number of patients with on-treatment virologic failure
Measured: End of treatment (Week 48)
Number of patients with viral relapse
Measured: Up to 24 weeks after end of treatment
Number of patients with presence of HCV variants associated with reduced susceptibility to investigational treatment
Measured: Up to 24 weeks after end of treatment
Maximum plasma analyte concentration of TMC435
Measured: Week 4
Minimum plasma analyte concentration of TMC435
Measured: Week 4
Area under the plasma concentration-time curve of TMC435
Measured: Week 4
Maximum plasma analyte concentration of TMC647055
Measured: Week 4
Minimum plasma analyte concentration of TMC647055
Measured: Week 4
Area under the plasma concentration-time curve of TMC647055
Measured: Week 4
Maximum plasma analyte concentration of ritonavir (RTV)
Measured: Week 4
Minimum plasma analyte concentration of RTV
Measured: Week 4
Area under the plasma concentration-time curve of RTV
Measured: Week 4
Minimum and maximum plasma concentrations of GSK233680k
Measured: Week 4
Area under the plasma concentration-time curve of GSK233680k
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen R&D Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen R&D Ireland Clinical Trial, Study director, Janssen R&D Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724086
- Sponsor's protocol ID
- CR100882
- Other IDs
- TMC647055HPC2001, 2012-002555-42
- Status last verified
- Jan 2016
- First submitted
- 26 Sep 2012
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vijgen L, Thys K, Vandebosch A, Van Remoortere P, Verloes R, De Meyer S. Virology analysis in HCV genotype 1-infected patients treated with the combination of simeprevir and TMC647055/ritonavir, with and without ribavirin, and JNJ-56914845. Virol J. 2017 May 31;14(1):101. doi: 10.1186/s12985-017-0760-2.
PubMed 28569206
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of a 12 Weeks Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Chronic Genotype 1 Hepatitis C Infected Patients
- ClinicalTrials.gov ID
- NCT01724086
- Acronym / sponsor ID
- CR100882
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Chronic hepatitis C-infected patients, TMC647055, TMC435, Ritonavir, Ribavirin, Genotype 1a, Genotype 1b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Janssen R&D IrelandIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and low-dose ritonavir, administered together with and without ribavirin and of TMC647055, TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a limited number of patients with chronic hepatitis C virus (HCV) infection.
Detailed description
This study is an open-label study (all people know the identity of the intervention) in patients who are chronically infected with hepatitis C virus (HCV) genotype-1a (GT1a) or genotype-1b (GT1b) to assess the safety, tolerability and efficacy of the coadministration of TMC647055, TMC435 and low-dose ritonavir (RTV), with and without ribavirin (RBV) and of TMC647055, TMC435, RTV administered together with GSK233680k without RBV for 12 weeks. Approximately 86 patients will be enrolled in this study. Patients enrolled in the study will be chronically infected with HCV of GT1a (n=10) or GT1b (n=20), either treatment-naive patients (ie, patients never having received PegIFN [Pegylated interferon alpha-2a at 180 mcg subcutaneous once a week], RBV, or any other approved or investigational treatment for chronic HCV infection) or patients who are relapsers to prior treatment with PegIFN /RBV (ie, "relapsers" are patients with HCV ribonucleic acid [RNA] undetectable at the last on treatment measurement of a prior PegIFN based regimen of at least 24 weeks, but HCV RNA detectable within 1 year after the last medication intake). Patients in this first part of the study will be divided over 4 panels: Panel 1 will consist of 10 chronic HCV GT1a infected treatment-naive patients/prior relapsers who will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose ritonavir and ribavirin. Panel 2 will consist of 20 chronic HCV GT1b infected treatment-naive patients/ prior relapsers who will be randomly allocated to 2 arms in a 1:1 ratio. Arm 1 (N=10) will receive TMC435 + TMC647055 + low-dose ritonavir and ribavirin. Arm 2 (N=10) will receive TMC435 + TMC647055 + low-dose ritonavir. Panel 3 will consist of 16 chronic HCV GT1a or GT1b infected treatment-naïve patients/prior relapsers who will be allocated to 2 arms: 8 HCV GT1a patients in arm 1 and 8 HCV GT1b patients in arm 2. Patients in Arm 1 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV and RBV and patients in Arm 2 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV. Panel 4 will consist of 40 chronic HCV GT1a or GT1b infected treatment-naïve patients/prior relapsers who will be allocated to 2 arms: each arm will consist of 20 patients of which at most 8 patients will be infected with HCV GT1b. Patients will be randomized in 1:1 ratio between the 2 arms whereby randomization will be stratified by genotype. Patients in Arm 1 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805. Patients in Arm 2 will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805. The planned duration of the investigational treatment is 12 weeks. Patients in Panels 1, 2, and 3 may receive follow-up treatment with 12 weeks or 36 weeks of PegIFNα + RBV; follow-up treatment principles will not apply to Panel 4 as based on available proof of concept data for such combinations, the need for an additional 12 or 36-week PegIFN/RBV follow-up therapy is expected to be very low when evaluating a 12-week regimen of 3 direct acting antiviral agents for treatment of HCV genotype 1 infections. Safety will be monitored throughout the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Panel 1 | Experimental | Drug: TMC647055, Drug: TMC435, Drug: Ritonavir, Drug: Ribavirin, Drug: Pegylated interferon alpha-2a (PegIFN)10 chronic HCV genotype 1a (GT1a) infected treatment-naive patients/prior relapsers who will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose ritonavir and ribavirin. |
| Panel 2 Arm 1 | Experimental | Drug: TMC647055, Drug: TMC435, Drug: Ritonavir, Drug: Ribavirin, Drug: Pegylated interferon alpha-2a (PegIFN)10 chronic HCV GT1b infected treatment-naive patients/ prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir and ribavirin. |
| Panel 2 Arm 2 | Experimental | Drug: TMC647055, Drug: TMC435, Drug: Ritonavir, Drug: Ribavirin, Drug: Pegylated interferon alpha-2a (PegIFN)10 chronic HCV GT1b infected treatment-naive patients/ prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir. |
| Panel 3 - Arm 1 | Experimental | Drug: TMC647055, Drug: TMC435, Drug: Ritonavir, Drug: Ribavirin, Drug: Pegylated interferon alpha-2a (PegIFN)8 chronic HCV GT1a infected treatment naïve patients/prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir + ribavirin. |
| Panel 3 - Arm 2 | Experimental | Drug: TMC647055, Drug: TMC435, Drug: Ritonavir, Drug: Pegylated interferon alpha-2a (PegIFN)8 chronically HCV GT1b infected treatment naïve patients/prior relapsers will receive TMC435 + TMC647055 + low-dose ritonavir. |
| Panel 4 - Arm 1 | Experimental | Drug: TMC647055, Drug: TMC435, Drug: Ritonavir, Drug: GSK233680520 chronic HCV GT1a or GT1b infected treatment-naive patients/ prior relapsers will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805 (30 mg once daily) |
| Panel 4 - Arm 2 | Experimental | Drug: TMC647055, Drug: TMC435, Drug: Ritonavir, Drug: GSK233680520 chronic HCV GT1a or GT1b infected treatment-naive patients/ prior relapsers will receive 12 weeks of treatment with TMC435 + TMC647055 + low-dose RTV + GSK2336805 (60 mg once daily) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented chronic genotype 1a or genotype 1b hepatitis C virus (HCV) infection with HCV ribonucleic acid (RNA) level >100,000 IU/mL at screening
- Treatment-naive or documented prior relapser to previous treatment regimens and has stopped treatment at least 3 months before screening
- Liver biopsy within 3 years before the screening visit or elastography results available prior to first study drug dosing
- Medically stable based on physical examination, medical history, vital signs, and electrocardiogram performed at screening
- Body mass index of 18.0 to 32.0 kg/m2 and body weight more than 50 kg
Key exclusion criteria (5 listed)
- Evidence of liver cirrhosis by liver biopsy or the presence of esophageal varices or a transient elastography result of >14.6 kPa within 2 years prior to first dosing
- Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices
- Evidence of any significant liver disease in addition to hepatitis C (including but not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis)
- Receiving or has received any HCV-specific direct antiviral agent (HCV protease inhibitors, HCV nucleoside polymerase inhibitors, HCV non-nucleoside polymerase inhibitors, HCV NS5a inhibitors or any other HCV inhibitor targeting an HCV protein or a target involved in the HCV replication cycle
- Co-infected with human immunovirus (HIV)-1 or HIV-2, with non-genotype 1a/1b HCV, or hepatitis A or B virus infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMC647055Also: JNJ-42039556-AMR-G-001Type=exact number, unit=mg, number=150, form=capsule, route=oral. 3 or 4 capsules of 150 mg will be administered once daily. | Drug | Panel 1, Panel 2 Arm 1, Panel 2 Arm 2, Panel 3 - Arm 1, Panel 3 - Arm 2, Panel 4 - Arm 1, Panel 4 - Arm 2 |
| TMC435Type=exact number, unit=mg, number=75, form=capsule, route=oral. 1 capsule of 75 mg will be administered once daily. | Drug | Panel 1, Panel 2 Arm 1, Panel 2 Arm 2, Panel 3 - Arm 1, Panel 3 - Arm 2, Panel 4 - Arm 1, Panel 4 - Arm 2 |
| RitonavirType=exact number, unit=mg, number=30 or 50, form=tablet or solution, route=oral. 0.375 mL or 0.625 ml (80 mg/mL) solution will be administered once daily. | Drug | Panel 1, Panel 2 Arm 1, Panel 2 Arm 2, Panel 3 - Arm 1, Panel 3 - Arm 2, Panel 4 - Arm 1, Panel 4 - Arm 2 |
| RibavirinType=exact number, unit=mg, number=200, form=tablet, route=oral. 5 to 6 (1000 or 1200 mg) tablets will be administered once daily, divided in 2 daily doses. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment 5 or 6 (depending on bodyweight) tablets of ribavirin (equivalent to 200 mg/tablet) per day, divided in 2 daily doses for an additional 12 or 36 weeks. | Drug | Panel 1, Panel 2 Arm 1, Panel 2 Arm 2, Panel 3 - Arm 1 |
| Pegylated interferon alpha-2a (PegIFN)Type=exact number, unit=mcg, number=180, form=solution, route=subcutaneous injection. PegIFN 0.5 mL prefilled syringe equivalent to 180 mcg will be administered as a subcutaneous (under the skin) injection as follow-up (FU) treatment for 12 or 36 weeks based on follow-up treatment principles as described in the protocol. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment with Pegylated interferon alpha-2a (PegIFN) 0.5 mL prefilled syringe equivalent to 180 mcg administered as a subcutaneous (under the skin) injection for an additional 12 or 36 weeks. | Drug | Panel 1, Panel 2 Arm 1, Panel 2 Arm 2, Panel 3 - Arm 1, Panel 3 - Arm 2 |
| GSK2336805Type=exact number, unit=mg, number=30 or 60, form=tablet, route=subcutaneous injection. GSK2336805 one or two 30 mg tablet(s) taken orally (by mouth) once daily for 12 weeks. | Drug | Panel 4 - Arm 1, Panel 4 - Arm 2 |
Primary outcome
Number of patients with a sustained virologic response (SVR) 12 Weeks after the actual end of treatment
Time frame: Week 24 (Up to 12 weeks after end-of treatment visit)
SVR12 is defined as undetectable HCV RNA at the actual end of treatment and HCV RNA less than 25 IU/mL at 12 Weeks after the actual end of treatment.
Number of patients with adverse events
Time frame: Up to Week 48 (24 weeks after end of treatment)
Number of patients with adverse events, serious adverse events, abnormal changes in safety related laboratory values, abnormal changes in vital signs and physical examination, and abnormal echocardiogram.
17 secondary outcomes
Number of patients with a sustained virological response (SVR at 4 and/or 24 Weeks after the actual end of treatment)
Time frame: Up to 24 weeks after end of treatment
HCV RNA levels over time
Time frame: Up to 24 weeks after end of treatment
Number of patients with undetectable hepatitis C virus (HCV) RNA (less than 25 IU/mL undetectable) and/or HCV RNA levels less than 25 IU/mL at all time points
Time frame: Up to 24 weeks after end of treatment
Number of patients with on-treatment virologic failure
Time frame: End of treatment (Week 48)
Number of patients with viral relapse
Time frame: Up to 24 weeks after end of treatment
Number of patients with presence of HCV variants associated with reduced susceptibility to investigational treatment
Time frame: Up to 24 weeks after end of treatment
Maximum plasma analyte concentration of TMC435
Time frame: Week 4
Minimum plasma analyte concentration of TMC435
Time frame: Week 4
Area under the plasma concentration-time curve of TMC435
Time frame: Week 4
Maximum plasma analyte concentration of TMC647055
Time frame: Week 4
Minimum plasma analyte concentration of TMC647055
Time frame: Week 4
Area under the plasma concentration-time curve of TMC647055
Time frame: Week 4
Maximum plasma analyte concentration of ritonavir (RTV)
Time frame: Week 4
Minimum plasma analyte concentration of RTV
Time frame: Week 4
Area under the plasma concentration-time curve of RTV
Time frame: Week 4
Minimum and maximum plasma concentrations of GSK233680k
Time frame: Week 4
Area under the plasma concentration-time curve of GSK233680k
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Derived from this study: PubMed 28569206Vijgen L, Thys K, Vandebosch A, Van Remoortere P, Verloes R, De Meyer S. Virology analysis in HCV genotype 1-infected patients treated with the combination of simeprevir and TMC647055/ritonavir, with and without ribavirin, and JNJ-56914845. Virol J. 2017 May 31;14(1):101. doi: 10.1186/s12985-017-0760-2.
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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen R&D Ireland Clinical Trial study director
Janssen R&D Ireland
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC647055, TMC435 and Ritonavir in people with Chronic Hepatitis C, run by Janssen R&D Ireland at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a sustained virologic response (SVR) 12 Weeks after the actual end of treatment (time frame: Week 24 (Up to 12 weeks after end-of treatment visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.