Chronic Hepatitis C VirusPhase 2NCT01852604

Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)

A Phase 2 study testing Samatasvir, Simeprevir and Ribavirin (RBV) in people with Chronic Hepatitis C Virus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis C Virus
What is being tested?: Samatasvir, Simeprevir and Ribavirin (RBV)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 143 participants
Where: No sites listed yet
Study dates: Mar 2013to Apr 2015
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must have Genotype 1a, 1b, 4 or 6 HCV infection.
Documented clinical history compatible with chronic hepatitis C
HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C)
Must agree to use an acceptable double method of birth control (one of which must be a barrier method) for at least 6 months after the last dose of study drugs.

Who cannot join

Female participants who are pregnant or breastfeeding.
Body Mass Index (BMI) > 36 kg/m2.
Co-infected with hepatitis B virus or human immunodeficiency virus (HIV).
History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
Has one or more known primary or secondary causes of liver disease, other than hepatitis C
History of, or active, acute or chronic, liver or biliary injury due to drugs, toxins, non-HCV viral hepatitis, gallstones or other etiologies
Donated blood or had significant blood loss 30 days prior to dosing

About this study

Official title: A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection

Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.

Read the detailed description

Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.

Conditions: Chronic Hepatitis C Virus
Being tested: Samatasvir, Simeprevir, Ribavirin (RBV), TMC647055, Ritonavir (RTV)
Keywords: HCV, Hepatitis C, chronic hepatitis C, antiviral
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SamatasvirDrug
Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.
SimeprevirDrug
Simeprevir will be supplied as 75 and 150 mg oral capsules.
Ribavirin (RBV)Drug
Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.
TMC647055Drug
TMC647055 will be supplied as 150 mg oral capsules.
Ritonavir (RTV)Drug
Ritonavir will be supplied as 80 mg/mL oral solution.
Pegylated interferon (Peg-IFN)Biological
Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.
Samatasvir matching placeboOther
Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.

Study groups in NCT01852604
Study group	Role	What they receive
Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV	Experimental	Part A: Participants with genotype 1b or 4 received samatasvir 50 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Biological: Pegylated interferon (Peg-IFN); Other: Samatasvir matching placebo
Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV	Experimental	Part A: Participants with genotype 1b or 4 received samatasvir 100 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Biological: Pegylated interferon (Peg-IFN); Other: Samatasvir matching placebo
Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV	Experimental	Part A: Participants with genotype 1b or 4 received samatasvir 150 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Biological: Pegylated interferon (Peg-IFN)
Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV	Experimental	Part B: Participants with genotype 1b or 4 received samatasvir 25 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Biological: Pegylated interferon (Peg-IFN)
Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV	Experimental	Part B: Participants with genotype 1b or 4 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Biological: Pegylated interferon (Peg-IFN)
Part B: GT 6 - samatasvir 100/simeprevir/RBV	Experimental	Part B: Participants with Genotype 6 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Biological: Pegylated interferon (Peg-IFN)
Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV	Experimental	Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Drug: TMC647055; Drug: Ritonavir (RTV); Biological: Pegylated interferon (Peg-IFN)
Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV	Experimental	Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks Receives: Drug: Samatasvir; Drug: Simeprevir; Drug: Ribavirin (RBV); Drug: TMC647055; Drug: Ritonavir (RTV); Biological: Pegylated interferon (Peg-IFN)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of participants who experienced an adverse event (AE)
Measured: Up to approximately 95 weeks
Percentage of participants who experienced a serious adverse event (SAE)
Measured: Up to approximately 95 weeks
Percentage of participants who experienced a Grade 1-4 laboratory abnormality
Measured: Up to 66 weeks
Percentage of participants who experienced sustained virologic response 4 weeks after the end of treatment (SVR4)
Measured: Up to 16 weeks

Secondary outcomes (8)

Percentage of participants who experienced rapid virologic response (RVR)
Measured: Week 4
Percentage of participants who experienced early virologic response (EVR)
Measured: Week 12
Percentage of participants who experienced sustained virologic response 8 weeks after the end of treatment (SVR8)
Measured: Up to 20 weeks
Percentage of participants who experienced sustained virologic response 12 weeks after the end of treatment (SVR12)
Measured: Up to 24 weeks
Percentage of participants who experienced sustained virologic response 24 weeks after the end of treatment (SVR24)
Measured: Up to 36 weeks
Pharmacokinetic Parameter:Area under the concentration-time curve from time zero to t
Measured: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)
Measured: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
Pharmacokinetic Parameter: Trough drug concentration (Ctrough)
Measured: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Apr 2015

First posted14 May 2013 (estimated)
Study startMar 2013
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis C VirusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01852604
Sponsor's protocol ID: 1894-005
Other IDs: IDX-06A-005
Status last verified: Apr 2015
First submitted: 6 May 2013
Last updated: 23 Apr 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
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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
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
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

All Chronic Hepatitis C Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT01852604
Acronym / sponsor ID: 1894-005
Conditions: Chronic Hepatitis C Virus
Keywords: HCV, Hepatitis C, chronic hepatitis C, antiviral
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Janssen Research & Development, LLC
Study start: Mar 2013
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 14 May 2013 (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.

Detailed description

Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Biological: Pegylated interferon (Peg-IFN), Other: Samatasvir matching placeboPart A: Participants with genotype 1b or 4 received samatasvir 50 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks
Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Biological: Pegylated interferon (Peg-IFN), Other: Samatasvir matching placeboPart A: Participants with genotype 1b or 4 received samatasvir 100 mg and samatasvir matching placebo once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks
Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Biological: Pegylated interferon (Peg-IFN)Part A: Participants with genotype 1b or 4 received samatasvir 150 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks
Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Biological: Pegylated interferon (Peg-IFN)Part B: Participants with genotype 1b or 4 received samatasvir 25 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks
Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Biological: Pegylated interferon (Peg-IFN)Part B: Participants with genotype 1b or 4 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks
Part B: GT 6 - samatasvir 100/simeprevir/RBV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Biological: Pegylated interferon (Peg-IFN)Part B: Participants with Genotype 6 received samatasvir 100 mg once daily, plus simeprevir 150 mg capsule once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks
Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Drug: TMC647055, Drug: Ritonavir (RTV), Biological: Pegylated interferon (Peg-IFN)Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily plus RTV 30 mg once daily for 12 weeks
Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV	Experimental	Drug: Samatasvir, Drug: Simeprevir, Drug: Ribavirin (RBV), Drug: TMC647055, Drug: Ritonavir (RTV), Biological: Pegylated interferon (Peg-IFN)Part C: Participants with Genotype 1a or 1b received samatasvir 50 mg once daily, plus simeprevir 75 mg capsule once daily, plus TMC647055 450 mg once daily, plus RTV 30 mg once daily, plus RBV (dosing weight-based, according to product label) twice daily for 12 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must have Genotype 1a, 1b, 4 or 6 HCV infection.
Documented clinical history compatible with chronic hepatitis C
HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C)
Must agree to use an acceptable double method of birth control (one of which must be a barrier method) for at least 6 months after the last dose of study drugs.

Key exclusion criteria (8 listed)

Female participants who are pregnant or breastfeeding.
Body Mass Index (BMI) > 36 kg/m2.
Co-infected with hepatitis B virus or human immunodeficiency virus (HIV).
History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.

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
SamatasvirSamatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.	Drug	Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV, Part B: GT 6 - samatasvir 100/simeprevir/RBV, Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV, Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV
SimeprevirSimeprevir will be supplied as 75 and 150 mg oral capsules.	Drug	Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV, Part B: GT 6 - samatasvir 100/simeprevir/RBV, Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV, Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV
Ribavirin (RBV)Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.	Drug	Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV, Part B: GT 6 - samatasvir 100/simeprevir/RBV, Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV, Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV
TMC647055TMC647055 will be supplied as 150 mg oral capsules.	Drug	Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV, Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV
Ritonavir (RTV)Ritonavir will be supplied as 80 mg/mL oral solution.	Drug	Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV, Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV
Pegylated interferon (Peg-IFN)Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.	Biological	Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 150/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part B: GT 1b, 4 - samatasvir 25/simeprevir/RBV, Part B: GT 6 - samatasvir 100/simeprevir/RBV, Part C: GT 1a, 1b - samatasvir 50/simeprevir/TCM647055/RTV, Part C: GT 1a, 1b - samatasvir 50/simeprivir/TCM647055/RTV/RBV
Samatasvir matching placeboSamatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.	Other	Part A: GT 1b, 4 - samatasvir 100/simeprevir/RBV, Part A: GT 1b, 4 - samatasvir 50/simeprevir/RBV

Primary outcome

Percentage of participants who experienced an adverse event (AE)
Time frame: Up to approximately 95 weeks
Percentage of participants who experienced a serious adverse event (SAE)
Time frame: Up to approximately 95 weeks
Percentage of participants who experienced a Grade 1-4 laboratory abnormality
Time frame: Up to 66 weeks
Percentage of participants who experienced sustained virologic response 4 weeks after the end of treatment (SVR4)
Time frame: Up to 16 weeks

8 secondary outcomes

Percentage of participants who experienced rapid virologic response (RVR)
Time frame: Week 4
Percentage of participants who experienced early virologic response (EVR)
Time frame: Week 12
Percentage of participants who experienced sustained virologic response 8 weeks after the end of treatment (SVR8)
Time frame: Up to 20 weeks
Percentage of participants who experienced sustained virologic response 12 weeks after the end of treatment (SVR12)
Time frame: Up to 24 weeks
Percentage of participants who experienced sustained virologic response 24 weeks after the end of treatment (SVR24)
Time frame: Up to 36 weeks
Pharmacokinetic Parameter:Area under the concentration-time curve from time zero to t
Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)
Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
Pharmacokinetic Parameter: Trough drug concentration (Ctrough)
Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84

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 23 Apr 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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Samatasvir, Simeprevir and Ribavirin (RBV) in people with Chronic Hepatitis C Virus, run by Merck Sharp & Dohme LLC.

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 4 inclusion and 8 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Percentage of participants who experienced an adverse event (AE) (time frame: Up to approximately 95 weeks). The study lists 4 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 NCT01852604.

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 23 Apr 2015.