Hepatitits CPhase 2GALAXYNCT02165189

An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

A Phase 2 study testing Simeprevir, Sofosbuvir and Ribavirin in people with Hepatitits C, run by Janssen Scientific Affairs, LLC at 11 sites in United States.

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

The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants with recurrent… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitits C
What is being tested?: Simeprevir, Sofosbuvir and Ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 11 sitesUnited States
Study dates: Aug 2014to Nov 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be infected with Hepatitis C virus (HCV) Genotype 1 (1a or 1b) with Baseline HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL). Retesting of HCV RNA to assess eligibility will be allowed once, using an unscheduled visit during the Screening period
Participant must have had an orthotopic liver transplant greater than or equal to (>=) 6 months to 15 years prior to enrollment
Participant must have had primary liver transplant
Participant must be on a stable immunosuppressive regimen for at least 3 months prior to the Screening visit. Immunosuppression regimens may include calcineurin inhibitors (for example, tacrolimus), mammalian target of rapamycin (mTOR) inhibitor, mycophenolate mofetil, prednisone, prednisolone less than or equal to (<=) 5 milligram per day (mg/day), other corticosteroids (except systemic dexamethasone), sirolimus, everolimus, or azathioprine. Stable immunosuppression includes normal adjustment of immunosuppressant dose but excludes changes in immunosuppressant medication and/or treatment of rejection.
Participant's renal function as measured by the Cockcroft Gault formula must be >30 milliliter per minute (mL/min)

Who cannot join

Participants received prior treatment with an investigational or Food and Drug Administration (FDA) approved direct-acting antiviral drug for the treatment of hepatitis C. Prior HCV treatment with interferon or peginterferon with or without ribavirin (RBV) is allowed but must have been completed at least 3 months prior to Screening
Participants with hepatic decompensation defined by any of the following: 1) Any post-liver transplant clinical signs including ascites, hepatic encephalopathy, and/or evidence of varices with or without variceal bleeding, and 2) Child-Turcotte-Pugh (CTP) score >=7
Participant has (post-transplant) any underlying serious or life-threatening condition, such as severe uncontrolled cardiopulmonary disease, vascular disease, rheumatologic condition, renal failure, dialysis, ongoing systemic infection, uncontrolled malignancy, or other serious illness that would compromise adherence to medications and ability to comply with all aspects of the study protocol
Any other active, clinically significant disease or clinically significant findings during the Screening period of medical history, physical examination, laboratory testing, or electrocardiogram (ECG) recording that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study. Retesting of laboratory results that lead to exclusion will be allowed once using an unscheduled visit during the Screening period to assess eligibility
Participant is a woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of ribavirin (or longer when dictated by local regulations)

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Study site
Ann Arbor, Michigan
Study site
Aurora, Colorado
Study site
Boston, Massachusetts
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Gainesville, Florida
Study site
Miami, Florida
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania

Other trials in United States

About this study

Official title: A Phase 2 Open-Label Study in Patients With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant to Explore the Safety And Efficacy of Simeprevir and Sofosbuvir With and Without Ribavirin

Read the detailed description

This is a Phase 2, multicenter (when more than one hospital or medical school team work on a medical research study), partially randomized (study drug is assigned by chance), and open-label (all people know the identity of the intervention) study to explore the safety and efficacy of simeprevir plus sofosbuvir. The study will consist of a screening period (Screening and Baseline), followed by randomization. First 33 non-cirrhotic participants will be randomly assigned in a ratio of 1:1:1 into 1 of 3 treatment arms, and up to 12 cirrhotic participants will be enrolled and all will be assigned to Arm 3. All participants in treatment Arms 1 and 2 will return for treatment visits at Weeks 1, 2, 4, 8, 12, and post-treatment follow-up visits on Weeks 16 and 24. All participants in treatment Arm 3 will return for treatment visits at Weeks 1, 2, 4, 8, 12, 16, 20, and 24, and post-treatment follow-up visits on Weeks 28 and 36. Participants will receive simeprevir plus sofosbuvir and RBV for a 12-week treatment period in Arm 1, simeprevir plus sofosbuvir without RBV for a 12-week treatment period in Arm 2 and simeprevir plus sofosbuvir for a 24-week treatment period in Arm 3. Efficacy will primarily be evaluated by SVR12. Participants' safety will be monitored throughout the study.

Conditions: Hepatitits C
Being tested: Simeprevir, Sofosbuvir, Ribavirin
Keywords: Simeprevir, Sofosbuvir, Ribavirin, Hepatitits C, Hepatitis C virus ribonucleic acid

What participants receive

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

SimeprevirDrug
Participants will be administered simeprevir capsule 150 mg orally once daily up to 12 weeks.
SofosbuvirDrug
Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 12 weeks.
RibavirinDrug
Participants will be administered ribavirin 2 x 200 mg tablets (for participants weighing less than 75 kilogram ([kg]) or 3 x 200 mg tablets (for participants weighing more than 75 kg) orally once daily up to 12 weeks.
SimeprevirDrug
Participants will be administered simeprevir capsule 150 mg orally once daily up to 24 weeks.
SofosbuvirDrug
Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 24 weeks.

Study groups in NCT02165189
Study group	Role	What they receive
Simeprevir plus Sofosbuvir plus Ribavirin (Arm 1)	Experimental	Participants will be administered simeprevir capsule 150 milligram (mg), sofosbuvir 400 mg tablet, and ribavirin 2 x 200 mg tablets (for participants weighing less than 75 kilogram [kg]) or 3 x 200 mg tablets (for participants weighing more than 75 kg weight), orally once daily up to 12 weeks. Receives: Drug: Simeprevir; Drug: Sofosbuvir; Drug: Ribavirin
Simeprevir plus Sofosbuvir (Arm 2)	Experimental	Participants will be administered simeprevir capsule 150 mg and sofosbuvir 400 mg tablet orally once daily up to 12 weeks. Receives: Drug: Simeprevir; Drug: Sofosbuvir
Simeprevir plus Sofosbuvir (Arm 3)	Experimental	Participants will be administered simeprevir 150 mg capsule and sofosbuvir 400 mg tablet orally once daily 24 weeks. Receives: Drug: Simeprevir; Drug: Sofosbuvir

What is being measured

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

Percentage of Participants With Sustained Virologic Response After 12 Weeks of end of Treatment (SVR12)
Participants will be considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) 15 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the end of treatment. End of treatment is at Week 12 (for Arms 1 and 2) or Week 24 (for Arm 3); therefore, outcome will be measured at Week 24 (for Arms 1 and 2) or Week 36 (for Arm 3).
Measured: Week 24 or Week 36

Secondary outcomes (6)

Percentage of Participants With Sustained Virologic Response After 4 Weeks of end of Treatment (SVR4)
Participants will be considered to have achieved SVR4 if the hepatitis C virus ribonucleic acid (HCV RNA) is <15 IU/mL (detectable or undetectable) at 4 weeks after the end of treatment.
Measured: Week 16 (for Arms 1 and 2) and Week 28 (for Arm 3)
Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)
Plasma HCV RNA will be determined using an in vitro nucleic acid amplification test for the quantification of HCV RNA in human plasma using a sensitive assay (COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0 , lower limit of quantification = limit of detection = 15 IU/mL).
Measured: Weeks 2, 4, 8 and 12 (for all treatment arms) and Weeks 16 20, and 24 (for Arm 3)
Percentage of Participants With Viral Breakthrough
Viral breakthrough is defined as confirmed greater than (>) 1.0 Log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <15 IU/mL.
Measured: Baseline up to Week 24 (for Arms 1 and 2) and Baseline up to Week 36 (for Arm 3)
Percentage of Participants With Viral Relapse
Participants will be considered to have viral relapse if they meet the following conditions: 1) HCV RNA <15 IU/mL (undetectable) at the end of treatment; and 2) HCV RNA greater than or equal to (>=) 15 IU/mL during the post-treatment follow-up period.
Measured: Baseline up to Week 24 (for Arms 1 and 2) and Baseline up to Week 36 (for Arm 3)
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Score at Week 24 (for Arms 1 and 2) and Week 36 (for Arm 3)
The HCV-SIQv4 is a self-administered questionnaire containing 33 items classified as 3 categories of scores: 1) Symptom severity score (sum of responses to 29 questions to assess severity or frequency of symptoms associated with HCV or its treatment; 2) Time missed from work/school (sum of responses to 3 questions regarding the impact of symptoms on work/school attendance); 3) Daily activity score (response to 1 question regarding the impact of symptoms on daily activities). Higher HCV SIQv4 scores indicate worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively. The total score is the sum of scores of these 3 categories.
Measured: Baseline, Week 24 (for Arms 1 and 2) and Week 36 (for Arm 3)
Change From Baseline in EuroQol 5 - Dimension (EQ-5D) Questionnaire Score at Weeks 4, 8, 12, 16, 20, 24 (for all treatment arms) and Week 36 (for Arm 3)
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. EQ-5D scores include EQ-5D valuation index score (a weighted scoring of the 5 dimension scores with a possible range from 0 to 1), EQ-5D visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health), and EQ5D descriptive system scores (five scores reflecting each of the 5 EQ-5D health dimensions ranging from 0 [no limitation] to 4 [incapacity]).
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24 (for all treatment arms) and Week 36 (for Arm 3)

Timeline

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

Aug 2014Nov 2015

First posted17 Jun 2014 (estimated)
Study startAug 2014
Primary completionNov 2015
Study completionNov 2015

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 Hepatitits 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: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02165189
Sponsor's protocol ID: CR104281
Other IDs: TMC435HPC2009
Acronym: GALAXY
Status last verified: Nov 2016
First submitted: 10 Jun 2014
Last updated: 11 Nov 2016
Results posted: No
Data monitoring committee: No

Publications

O'Leary JG, Fontana RJ, Brown K, Burton JR Jr, Firpi-Morell R, Muir A, O'Brien C, Rabinovitz M, Reddy R, Ryan R, Shprecher A, Villadiego S, Prabhakar A, Brown RS Jr. Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study. Transpl Int. 2017 Feb;30(2):196-208. doi: 10.1111/tri.12896. Epub 2017 Jan 20.
PubMed 27896858

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Open-Label Study in Patients With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant to Explore the Safety And Efficacy of Simeprevir and Sofosbuvir With and Without Ribavirin
ClinicalTrials.gov ID: NCT02165189
Acronym / sponsor ID: GALAXY / CR104281
Conditions: Hepatitits C
Keywords: Simeprevir, Sofosbuvir, Ribavirin, Hepatitits C, Hepatitis C virus ribonucleic acid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 17 Jun 2014 (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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Simeprevir plus Sofosbuvir plus Ribavirin (Arm 1)	Experimental	Drug: Simeprevir, Drug: Sofosbuvir, Drug: RibavirinParticipants will be administered simeprevir capsule 150 milligram (mg), sofosbuvir 400 mg tablet, and ribavirin 2 x 200 mg tablets (for participants weighing less than 75 kilogram [kg]) or 3 x 200 mg tablets (for participants weighing more than 75 kg weight), orally once daily up to 12 weeks.
Simeprevir plus Sofosbuvir (Arm 2)	Experimental	Drug: Simeprevir, Drug: SofosbuvirParticipants will be administered simeprevir capsule 150 mg and sofosbuvir 400 mg tablet orally once daily up to 12 weeks.
Simeprevir plus Sofosbuvir (Arm 3)	Experimental	Drug: Simeprevir, Drug: SofosbuvirParticipants will be administered simeprevir 150 mg capsule and sofosbuvir 400 mg tablet orally once daily 24 weeks.

Who may qualify

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

Key inclusion criteria (5 listed)

Participant must be infected with Hepatitis C virus (HCV) Genotype 1 (1a or 1b) with Baseline HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL). Retesting of HCV RNA to assess eligibility will be allowed once, using an unscheduled visit during the Screening period
Participant must have had an orthotopic liver transplant greater than or equal to (>=) 6 months to 15 years prior to enrollment
Participant must have had primary liver transplant
Participant must be on a stable immunosuppressive regimen for at least 3 months prior to the Screening visit. Immunosuppression regimens may include calcineurin inhibitors (for example, tacrolimus), mammalian target of rapamycin (mTOR) inhibitor, mycophenolate mofetil, prednisone, prednisolone less than or equal to (<=) 5 milligram per day (mg/day), other corticosteroids (except systemic dexamethasone), sirolimus, everolimus, or azathioprine. Stable immunosuppression includes normal adjustment of immunosuppressant dose but excludes changes in immunosuppressant medication and/or treatment of rejection.
Participant's renal function as measured by the Cockcroft Gault formula must be >30 milliliter per minute (mL/min)

Key exclusion criteria (5 listed)

Participants received prior treatment with an investigational or Food and Drug Administration (FDA) approved direct-acting antiviral drug for the treatment of hepatitis C. Prior HCV treatment with interferon or peginterferon with or without ribavirin (RBV) is allowed but must have been completed at least 3 months prior to Screening
Participants with hepatic decompensation defined by any of the following: 1) Any post-liver transplant clinical signs including ascites, hepatic encephalopathy, and/or evidence of varices with or without variceal bleeding, and 2) Child-Turcotte-Pugh (CTP) score >=7
Participant has (post-transplant) any underlying serious or life-threatening condition, such as severe uncontrolled cardiopulmonary disease, vascular disease, rheumatologic condition, renal failure, dialysis, ongoing systemic infection, uncontrolled malignancy, or other serious illness that would compromise adherence to medications and ability to comply with all aspects of the study protocol
Any other active, clinically significant disease or clinically significant findings during the Screening period of medical history, physical examination, laboratory testing, or electrocardiogram (ECG) recording that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study. Retesting of laboratory results that lead to exclusion will be allowed once using an unscheduled visit during the Screening period to assess eligibility
Participant is a woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of ribavirin (or longer when dictated by local regulations)

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
SimeprevirParticipants will be administered simeprevir capsule 150 mg orally once daily up to 12 weeks.	Drug	Simeprevir plus Sofosbuvir (Arm 2), Simeprevir plus Sofosbuvir plus Ribavirin (Arm 1)
SofosbuvirParticipants will be administered sofosbuvir 400 mg tablet orally once daily up to 12 weeks.	Drug	Simeprevir plus Sofosbuvir (Arm 2), Simeprevir plus Sofosbuvir plus Ribavirin (Arm 1)
RibavirinParticipants will be administered ribavirin 2 x 200 mg tablets (for participants weighing less than 75 kilogram ([kg]) or 3 x 200 mg tablets (for participants weighing more than 75 kg) orally once daily up to 12 weeks.	Drug	Simeprevir plus Sofosbuvir plus Ribavirin (Arm 1)
SimeprevirParticipants will be administered simeprevir capsule 150 mg orally once daily up to 24 weeks.	Drug	Simeprevir plus Sofosbuvir (Arm 3)
SofosbuvirParticipants will be administered sofosbuvir 400 mg tablet orally once daily up to 24 weeks.	Drug	Simeprevir plus Sofosbuvir (Arm 3)

Primary outcome

Percentage of Participants With Sustained Virologic Response After 12 Weeks of end of Treatment (SVR12)
Time frame: Week 24 or Week 36
Participants will be considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) 15 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the end of treatment. End of treatment is at Week 12 (for Arms 1 and 2) or Week 24 (for Arm 3); therefore, outcome will be measured at Week 24 (for Arms 1 and 2) or Week 36 (for Arm 3).

6 secondary outcomes

Percentage of Participants With Sustained Virologic Response After 4 Weeks of end of Treatment (SVR4)
Time frame: Week 16 (for Arms 1 and 2) and Week 28 (for Arm 3)
Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)
Time frame: Weeks 2, 4, 8 and 12 (for all treatment arms) and Weeks 16 20, and 24 (for Arm 3)
Percentage of Participants With Viral Breakthrough
Time frame: Baseline up to Week 24 (for Arms 1 and 2) and Baseline up to Week 36 (for Arm 3)
Percentage of Participants With Viral Relapse
Time frame: Baseline up to Week 24 (for Arms 1 and 2) and Baseline up to Week 36 (for Arm 3)
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Score at Week 24 (for Arms 1 and 2) and Week 36 (for Arm 3)
Time frame: Baseline, Week 24 (for Arms 1 and 2) and Week 36 (for Arm 3)
Change From Baseline in EuroQol 5 - Dimension (EQ-5D) Questionnaire Score at Weeks 4, 8, 12, 16, 20, 24 (for all treatment arms) and Week 36 (for Arm 3)
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24 (for all treatment arms) and Week 36 (for Arm 3)

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 Nov 2016.
Derived from this study: PubMed 27896858O'Leary JG, Fontana RJ, Brown K, Burton JR Jr, Firpi-Morell R, Muir A, O'Brien C, Rabinovitz M, Reddy R, Ryan R, Shprecher A, Villadiego S, Prabhakar A, Brown RS Jr. Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study. Transpl Int. 2017 Feb;30(2):196-208. doi: 10.1111/tri.12896. Epub 2017 Jan 20.
A Phase 2 Open-label Study in Patients With Recurrent Genotype 1 Hepatitis C Postorthotopic Liver Transplant to Explore the Safety and Efficacy of Simeprevir and Sofosbuvir With and Without Ribavirin.Link provided by the sponsor.

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 Scientific Affairs, LLC Clinical Trial study director

Janssen Scientific Affairs, LLC

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Simeprevir, Sofosbuvir and Ribavirin in people with Hepatitits C, run by Janssen Scientific Affairs, LLC at 11 sites in United States.

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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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?

Percentage of Participants With Sustained Virologic Response After 12 Weeks of end of Treatment (SVR12) (time frame: Week 24 or Week 36). 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 NCT02165189, 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 Nov 2016.