Renal ImpairmentPhase 2NCT02397395
An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
A Phase 2 study testing Simeprevir (SMV) 150 mg and Daclatasvir (DCV) 60 mg in people with Renal Impairment and End-stage Renal Disease, run by Janssen R&D Ireland at 6 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Impairment, End-stage Renal Disease
- What is being tested?
- Simeprevir (SMV) 150 mg and Daclatasvir (DCV) 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesin 2 countries
- Study dates
- May 2015to May 2016
- 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
- Man or woman, between 18 and 70 years of age, inclusive, at screening
- Hepatitis C Virus (HCV genotype): HCV genotype 1b or 4 (determined at screening)
- Plasma HCV RNA: Greater than (>) 10,000 international unit per milliliter (IU/mL) (determined at screening)
- HCV disease status: FibroScan less than (<) 14.5 kilopascal (kPa), performed within 3 months prior to screening, or between screening and baseline (Day 1), and no history or signs or symptoms of decompensated liver disease. In participants with FibroScan >12.5 kPa, absence of findings suspicious for hepatocellular carcinoma documented by an abdominal ultrasound, performed within 3 months prior to screening, or between screening and baseline (Day 1)
- HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
Who cannot join
- Infection/co-infection: HCV genotype other than 1b or 4, Human immunodeficiency virus type 1 or 2
- Liver disease of non-HCV etiology: Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, hepatitis B (hepatitis B surface antigen positive), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator
- Hepatic decompensation: History or evidence of clinical hepatic decompensation (presence of ascites, bleeding varices or hepatic encephalopathy)
- Organ transplantation/renal replacement therapy: Prior organ transplant (other than cornea, hair transplant or skin graft), except for history of kidney transplant with subsequent renal failure requiring hemodialysis and for which use of immunosuppressants has been discontinued; Considered for kidney transplant or imminent renal replacement therapy (including intermittent hemodialysis; continuous hemofiltration and hemodialysis; and peritoneal dialysis) for participants with severe renal impairment within a time frame that overlaps with study participation
- Key protocol defined laboratory abnormalities
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
About this study
Official title: A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
Read the detailed description
This is a Phase 2, open-label (identity of study drug will be known to volunteer and study staff), single-arm, multicenter (when more than one hospital work on a medical research study) study to evaluate the efficacy, safety, tolerability and pharmacokinetics of 12 weeks treatment with Simeprevir (SMV) and Daclatasvir (DCV) in participants with chronic Hepatitis C Virus (HCV) genotype 1b or 4 infection and either severe renal impairment or End-stage Renal Disease on hemodialysis. The study consists of a Screening Phase of 4 weeks, an Open-label Treatment Phase of 12 weeks, and a post-Treatment Follow-up Phase of 24 weeks. The total study duration for each participant will be approximately 40 weeks. All participants will receive a treatment regimen consisting of SMV 150 mg and DCV 60 mg co-administered once daily for a total treatment duration of 12 weeks. Participants who experience inadequate virologic response at Week 8 (defined as confirmed HCV RNA greater than or equal to [>=] lower limit of quantification [LLOQ]) or viral breakthrough at any on-treatment visit (defined as confirmed increase in HCV RNA of >1 log base 10 from nadir, or confirmed HCV RNA >100 International unit per milliliter [IU/mL] in participants whose HCV RNA had previously been <LLOQ while on treatment) should discontinue all study drugs. Participants will be primarily evaluated for sustained virologic response 12 weeks after the actual end of study treatment (SVR12). Participants' safety will be evaluated throughout the study duration.
- Conditions
- Renal Impairment, End-stage Renal Disease
- Being tested
- Simeprevir (SMV) 150 mg, Daclatasvir (DCV) 60 mg
- Keywords
- Renal Impairment, End-stage Renal Disease, Simeprevir, Daclatasvir
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simeprevir (SMV) 150 mgDrug
Simeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks.
Daclatasvir (DCV) 60 mgDrug
Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Simeprevir Co-administered with Daclatasvir | Experimental | All participants will receive Simeprevir (SMV) 150 milligram (mg) capsule co-administered with Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks. Participants should take the study drugs (SMV and DCV together) orally and once daily with food. Receives: Drug: Simeprevir (SMV) 150 mg; Drug: Daclatasvir (DCV) 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ)
, detectable or undetectable at 12 weeks after EOT.
Measured: 12 weeks after end of treatment (EOT) (Week 12 of follow-up phase)
Secondary outcomes (7)
Percentage of Participants With On-treatment Response
HCV RNA results satisfying a specified threshold. The following thresholds will be considered at any time point: <LLOQ undetectable, <LLOQ detectable, <LLOQ undetectable/detectable.
Measured: Baseline up to EOT (Week 12)
Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)
SVR4 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ) , detectable or undetectable at 4 weeks after EOT.
Measured: 4 weeks after EOT (Week 4 of follow-up phase)
Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)
SVR24 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ) , detectable or undetectable at 24 weeks after EOT.
Measured: 24 weeks after EOT (Week 24 of follow-up phase)
Percentage of Participants With on-treatment Failure
Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study treatment.
Measured: Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase)
Percentage of Participants With Viral Relapse
Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study treatment and confirmed HCV RNA >=LLOQ during 24-week follow-up.
Measured: EOT (Week 12) until end of follow-up phase (Week 24 of follow-up phase)
Change From Baseline in Hepatitis C Virus (HCV) Nonstructural Protein 3/4A (NS3/4A) and Nonstructural Protein 5A (NS5A) Sequence in Participants not Achieving SVR
Measured: Baseline until end of follow-up phase (Week 24 of follow-up phase)
Change From Baseline in HCV Symptom and Impact Questionnaire version 4 (HCV-SIQv4) Overall Body Symptom score
The HCV-SIQv4 is a self-administered questionnaire containing 33 items (ranging from 0=Not at All to 4=Extremely): 29 questions developed to assess the severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. Higher HCV-SIQv4 scores indicate worse symptom severity, more time missed from work or school, and more impairment in daily activities, respectively.
Measured: Baseline until end of follow-up phase (Week 24 of follow-up phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: Trial has been cancelled due to availability of new therapeutic options for patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02397395
- Sponsor's protocol ID
- CR106396
- Other IDs
- TMC435HPC2018, 2014-004250-34, 2014
- Status last verified
- Jul 2015
- First submitted
- 19 Mar 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
- ClinicalTrials.gov ID
- NCT02397395
- Acronym / sponsor ID
- CR106396
- Conditions
- Renal Impairment, End-stage Renal Disease
- Keywords
- Renal Impairment, End-stage Renal Disease, Simeprevir, Daclatasvir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial has been cancelled due to availability of new therapeutic options for patient population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen R&D IrelandIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 25 Mar 2015 (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 evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
Detailed description
This is a Phase 2, open-label (identity of study drug will be known to volunteer and study staff), single-arm, multicenter (when more than one hospital work on a medical research study) study to evaluate the efficacy, safety, tolerability and pharmacokinetics of 12 weeks treatment with Simeprevir (SMV) and Daclatasvir (DCV) in participants with chronic Hepatitis C Virus (HCV) genotype 1b or 4 infection and either severe renal impairment or End-stage Renal Disease on hemodialysis. The study consists of a Screening Phase of 4 weeks, an Open-label Treatment Phase of 12 weeks, and a post-Treatment Follow-up Phase of 24 weeks. The total study duration for each participant will be approximately 40 weeks. All participants will receive a treatment regimen consisting of SMV 150 mg and DCV 60 mg co-administered once daily for a total treatment duration of 12 weeks. Participants who experience inadequate virologic response at Week 8 (defined as confirmed HCV RNA greater than or equal to [>=] lower limit of quantification [LLOQ]) or viral breakthrough at any on-treatment visit (defined as confirmed increase in HCV RNA of >1 log base 10 from nadir, or confirmed HCV RNA >100 International unit per milliliter [IU/mL] in participants whose HCV RNA had previously been <LLOQ while on treatment) should discontinue all study drugs. Participants will be primarily evaluated for sustained virologic response 12 weeks after the actual end of study treatment (SVR12). Participants' safety will be evaluated throughout the study duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simeprevir Co-administered with Daclatasvir | Experimental | Drug: Simeprevir (SMV) 150 mg, Drug: Daclatasvir (DCV) 60 mgAll participants will receive Simeprevir (SMV) 150 milligram (mg) capsule co-administered with Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks. Participants should take the study drugs (SMV and DCV together) orally and once daily with food. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman, between 18 and 70 years of age, inclusive, at screening
- Hepatitis C Virus (HCV genotype): HCV genotype 1b or 4 (determined at screening)
- Plasma HCV RNA: Greater than (>) 10,000 international unit per milliliter (IU/mL) (determined at screening)
- HCV disease status: FibroScan less than (<) 14.5 kilopascal (kPa), performed within 3 months prior to screening, or between screening and baseline (Day 1), and no history or signs or symptoms of decompensated liver disease. In participants with FibroScan >12.5 kPa, absence of findings suspicious for hepatocellular carcinoma documented by an abdominal ultrasound, performed within 3 months prior to screening, or between screening and baseline (Day 1)
- HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
Key exclusion criteria (5 listed)
- Infection/co-infection: HCV genotype other than 1b or 4, Human immunodeficiency virus type 1 or 2
- Liver disease of non-HCV etiology: Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, hepatitis B (hepatitis B surface antigen positive), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator
- Hepatic decompensation: History or evidence of clinical hepatic decompensation (presence of ascites, bleeding varices or hepatic encephalopathy)
- Organ transplantation/renal replacement therapy: Prior organ transplant (other than cornea, hair transplant or skin graft), except for history of kidney transplant with subsequent renal failure requiring hemodialysis and for which use of immunosuppressants has been discontinued; Considered for kidney transplant or imminent renal replacement therapy (including intermittent hemodialysis; continuous hemofiltration and hemodialysis; and peritoneal dialysis) for participants with severe renal impairment within a time frame that overlaps with study participation
- Key protocol defined laboratory abnormalities
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 |
|---|---|---|
| Simeprevir (SMV) 150 mgSimeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks. | Drug | Simeprevir Co-administered with Daclatasvir |
| Daclatasvir (DCV) 60 mgDaclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks. | Drug | Simeprevir Co-administered with Daclatasvir |
Primary outcome
Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)
Time frame: 12 weeks after end of treatment (EOT) (Week 12 of follow-up phase)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ) , detectable or undetectable at 12 weeks after EOT.
7 secondary outcomes
Percentage of Participants With On-treatment Response
Time frame: Baseline up to EOT (Week 12)
Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)
Time frame: 4 weeks after EOT (Week 4 of follow-up phase)
Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)
Time frame: 24 weeks after EOT (Week 24 of follow-up phase)
Percentage of Participants With on-treatment Failure
Time frame: Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase)
Percentage of Participants With Viral Relapse
Time frame: EOT (Week 12) until end of follow-up phase (Week 24 of follow-up phase)
Change From Baseline in Hepatitis C Virus (HCV) Nonstructural Protein 3/4A (NS3/4A) and Nonstructural Protein 5A (NS5A) Sequence in Participants not Achieving SVR
Time frame: Baseline until end of follow-up phase (Week 24 of follow-up phase)
Change From Baseline in HCV Symptom and Impact Questionnaire version 4 (HCV-SIQv4) Overall Body Symptom score
Time frame: Baseline until end of follow-up phase (Week 24 of follow-up phase)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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
6 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 Simeprevir (SMV) 150 mg and Daclatasvir (DCV) 60 mg in people with Renal Impairment and End-stage Renal Disease, run by Janssen R&D Ireland at 6 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: withdrawn, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12) (time frame: 12 weeks after end of treatment (EOT) (Week 12 of follow-up phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2015.