Hepatitis, Viral, HumanPhase 1NCT01532973

Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)

A Phase 1 study testing Elbasvir in people with Hepatitis, Viral, Human, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II will enroll GT3 HCV-infected… Read more about this study

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: Hepatitis, Viral, Human
What is being tested?: Elbasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: No sites listed yet
Study dates: 16 Feb 2012to 17 May 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Body Mass Index (BMI) of 18 to ≤ 37 kg/m^2
Clinical diagnosis of chronic HCV infection defined by positive serology for HCV for at least 6 months and detectable HCV RNA in peripheral blood ≥105 IU/mL at screening
Participant must be infected with HCV GT1a, GT1b, or GT 3

Who cannot join

Co-infection with GT1 and GT3
Estimated creatinine clearance of ≤70 mL/min based on the Cockcroft-Gault equation
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of neoplastic disease
Positive Hepatitis B surface antigen at the pre-study (screening) visit

Show all 11Show fewer

Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
Previous treatments (s) with nonstructural protein 5A (NS5A) inhibitors
<4 weeks since administration of any experimental protease inhibitor
Previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of elbasvir in the study
Clinical or laboratory evidence of advanced or decompensated liver disease

About this study

Official title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males

Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).

Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants, the mean maximum reduction in HCV viral load is greater following multiple dose oral administration of elbasvir as compared to placebo.

Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).

Conditions: Hepatitis, Viral, Human
Being tested: Elbasvir, Placebo
Medical subject headings: Hepatitis, Viral, Human

What participants receive

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

ElbasvirDrug
Elbasvir was administered orally by tablet(s)
PlaceboDrug
Dose-matched placebo tablets were administered orally.

Study groups in NCT01532973
Study group	Role	What they receive
GT1 HCV 10-mg Elbasvir (Panel A)	Experimental	Participants with GT1 HCV receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. Receives: Drug: Elbasvir; Drug: Placebo
GTI HCV 50-g Elbasvir (Panel B)	Experimental	Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT1 HCV 5-mg Elbavir (Panel C)	Experimental	Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT1 HCV 200-mg Elbasvir (Panel D)	Experimental	Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT3 HCV 10-mg Elbasvir (Panel E)	Experimental	Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT3 HCV 50-mg Elbasvir (Panel F)	Experimental	Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT3 HCV 100-mg Elbasvir (Panel G)	Experimental	Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT3 HCV 200-mg Elbasvir (Panel H)	Experimental	Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT1a HCV 10-mg Elbasvir (Panel I)	Experimental	Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. Receives: Drug: Elbasvir; Drug: Placebo
GT1a HCV 50-mg Elbasvir (Panel J)	Experimental	Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study. Receives: Drug: Elbasvir; Drug: Placebo

What is being measured

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

Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
Measured: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5
Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction
Measured: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5
Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
Measured: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Measured: Up to 5 days
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Measured: Up to 5 days
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Measured: Up to 5 days
Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.
Measured: Up to 5 days
Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.
Measured: Up to 5 days

Timeline

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

16 Feb 201217 May 2013

First posted15 Feb 2012 (estimated)
Study start16 Feb 2012
Primary completion17 May 2013
Study completion17 May 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis, Viral, HumanStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01532973
Sponsor's protocol ID: 8742-002
Other IDs: 2011-005190-23
Status last verified: Jun 2018
First submitted: 10 Feb 2012
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Liu R, Curry S, McMonagle P, Yeh WW, Ludmerer SW, Jumes PA, Marshall WL, Kong S, Ingravallo P, Black S, Pak I, DiNubile MJ, Howe AY. Susceptibilities of genotype 1a, 1b, and 3 hepatitis C virus variants to the NS5A inhibitor elbasvir. Antimicrob Agents Chemother. 2015 Nov;59(11):6922-9. doi: 10.1128/AAC.01390-15. Epub 2015 Aug 24.
PubMed 26303801
Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25.
PubMed 29703432

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
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B

All Hepatitis, Viral, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males
ClinicalTrials.gov ID: NCT01532973
Acronym / sponsor ID: 8742-002
Conditions: Hepatitis, Viral, Human
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 16 Feb 2012 (actual)
Primary completion: 17 May 2013 (actual)
Study completion: 17 May 2013 (actual)
First posted: 15 Feb 2012 (estimated)
Results: Posted 23 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
GT1 HCV 10-mg Elbasvir (Panel A)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT1 HCV receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GTI HCV 50-g Elbasvir (Panel B)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GT1 HCV 5-mg Elbavir (Panel C)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GT1 HCV 200-mg Elbasvir (Panel D)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GT3 HCV 10-mg Elbasvir (Panel E)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT3 HCV 50-mg Elbasvir (Panel F)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT3 HCV 100-mg Elbasvir (Panel G)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT3 HCV 200-mg Elbasvir (Panel H)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT1a HCV 10-mg Elbasvir (Panel I)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
GT1a HCV 50-mg Elbasvir (Panel J)	Experimental	Drug: Elbasvir, Drug: PlaceboParticipants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Body Mass Index (BMI) of 18 to ≤ 37 kg/m^2
Clinical diagnosis of chronic HCV infection defined by positive serology for HCV for at least 6 months and detectable HCV RNA in peripheral blood ≥105 IU/mL at screening
Participant must be infected with HCV GT1a, GT1b, or GT 3

Key exclusion criteria (11 listed)

Co-infection with GT1 and GT3
Estimated creatinine clearance of ≤70 mL/min based on the Cockcroft-Gault equation
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of neoplastic disease

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
ElbasvirElbasvir was administered orally by tablet(s)	Drug	GT1 HCV 10-mg Elbasvir (Panel A), GT1 HCV 200-mg Elbasvir (Panel D), GT1 HCV 5-mg Elbavir (Panel C), GT1a HCV 10-mg Elbasvir (Panel I), GT1a HCV 50-mg Elbasvir (Panel J), GT3 HCV 10-mg Elbasvir (Panel E), GT3 HCV 100-mg Elbasvir (Panel G), GT3 HCV 200-mg Elbasvir (Panel H), GT3 HCV 50-mg Elbasvir (Panel F), GTI HCV 50-g Elbasvir (Panel B)
PlaceboDose-matched placebo tablets were administered orally.	Drug	GT1 HCV 10-mg Elbasvir (Panel A), GT1 HCV 200-mg Elbasvir (Panel D), GT1 HCV 5-mg Elbavir (Panel C), GT1a HCV 10-mg Elbasvir (Panel I), GT1a HCV 50-mg Elbasvir (Panel J), GT3 HCV 10-mg Elbasvir (Panel E), GT3 HCV 100-mg Elbasvir (Panel G), GT3 HCV 200-mg Elbasvir (Panel H), GT3 HCV 50-mg Elbasvir (Panel F), GTI HCV 50-g Elbasvir (Panel B)

Primary outcome

Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1
Time frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3
Time frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction
Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a
Time frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5
HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1
Time frame: Up to 5 days
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3
Time frame: Up to 5 days
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a
Time frame: Up to 5 days
HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.
Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5
Time frame: Up to 5 days
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.
Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event
Time frame: Up to 5 days
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.

Results and safety

Results posted to the registry on 23 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GT1 HCV 10-mg Elbasvir (Panel A)	6	6
GT1 HCV 50-g Elbasvir (Panel B)	6	6
GT1 HCV 5-mg Elbasvir (Panel C)	6	6
GT1 HCV 200-mg Elbasvir (Panel D)	0	0
GT3 HCV 10-mg Elbasvir (Panel E)	0	0
GT3 HCV 50-mg Elbasvir (Panel F)	0	0
GT3 HCV 100-mg Elbasvir (Panel G)	0	0
GT3 HCV 200-mg Elbasvir (Panel H)	0	0
GT1a HCV 10-mg Elbasvir (Panel I)	0	0
GT1a HCV 50-mg Elbasvir (Panel J)	0	0

Primary outcome: Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1

Time frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5. Least squares mean (95% Confidence Interval). Unit: IU/mL

Measure	GT1 HCV 10-mg Elbasvir (Panel A) n = 5	GT1 HCV 50-g Elbasvir (Panel B) n = 5	GT1 HCV 5-mg Elbasvir (Panel C) n = 5	Placebo n = 8
Value	4.25 (3.80 to 4.71)	4.40 (3.95 to 4.86)	3.56 (3.10 to 4.02)	0.00 (-0.37 to 0.36)

GT1 HCV 10-mg Elbasvir (Panel A) vs Placebo: Difference in LS Means: 4.26 (90% CI 3.77 to 4.74)
GT1 HCV 50-g Elbasvir (Panel B) vs Placebo: Difference in LS Means: 4.41 (90% CI 3.92 to 4.90)
GT1 HCV 5-mg Elbasvir (Panel C) vs Placebo: Difference in LS Means: 3.56 (90% CI 3.08 to 4.05)

Population analysed: All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.

Primary outcome: Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3

Time frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5. Least squares mean (95% Confidence Interval). Unit: IU/mL

Measure	GT3 HCV 10-mg Elbasvir (Panel E) n = 5	GT3 HCV 50-mg Elbasvir (Panel F) n = 5	GT3 HCV 100-mg Elbasvir (Panel G) n = 5	Placebo n = 8
Value	1.01 (0.38 to 1.65)	2.06 (1.43 to 2.70)	2.72 (2.08 to 3.35)	0.00 (-0.50 to 0.50)

GT3 HCV 10-mg Elbasvir (Panel E) vs Placebo: Difference in LS Means: 1.02 (90% CI 0.34 to 1.69)
GT3 HCV 50-mg Elbasvir (Panel F) vs Placebo: Difference in LS Means: 2.07 (90% CI 1.39 to 2.74)
GT3 HCV 100-mg Elbasvir (Panel G) vs Placebo: Difference in LS Means: 2.72 (90% CI 2.05 to 3.39)

Primary outcome: Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a

Time frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5. Least squares mean (95% Confidence Interval). Unit: IU/mL

Measure	GT1a HCV 10-mg Elbasvir (Panel I) n = 5	GT1a HCV 50-mg Elbasvir (Panel J) n = 5	Placebo n = 8
Value	3.20 (2.71 to 3.68)	3.95 (3.46 to 4.43)	0.00 (-0.39 to 0.38)

GT1a HCV 10-mg Elbasvir (Panel I) vs Placebo: Difference in LS Means: 3.20 (90% CI 2.68 to 3.72)
GT1a HCV 50-mg Elbasvir (Panel J) vs Placebo: Difference in LS Means: 3.95 (90% CI 3.44 to 4.47)

Primary outcome: Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1

Time frame: Up to 5 days. Least squares mean (95% Confidence Interval). Unit: IU/mL

Measure	GT1 HCV 10-mg Elbasvir (Panel A) n = 5	GT1 HCV 50-g Elbasvir (Panel B) n = 5	GT1 HCV 5-mg Elbasvir (Panel C) n = 5	Placebo n = 8
Value	4.44 (3.78 to 5.09)	5.21 (4.56 to 5.87)	4.15 (3.50 to 4.81)	0.54 (0.03 to 1.06)

GT1 HCV 10-mg Elbasvir (Panel A) vs Placebo: Difference in LS Means: 3.89 (90% CI 3.20 to 4.58)
GT1 HCV 50-g Elbasvir (Panel B) vs Placebo: Difference in LS Means: 4.67 (90% CI 3.98 to 5.36)
GT1 HCV 5-mg Elbasvir (Panel C): Difference in LS Means: 3.61 (90% CI 2.92 to 4.30)

Adverse events

Time frame: Days 1 to 5 for each panel and then up to 56 days post last dose for follow-up period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5-mg Elbasvir	0 of 5 (0%)	4 of 5 (80%)	Not reported
10-g Elbasvir	0 of 15 (0%)	6 of 15 (40%)	Not reported
50-mg Elbasvir	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
100-mg Elbasvir	0 of 5 (0%)	1 of 5 (20%)	Not reported
Placebo	0 of 8 (0%)	4 of 8 (50%)	Not reported
Post-Study	0 of 48 (0%)	0 of 48 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26303801Liu R, Curry S, McMonagle P, Yeh WW, Ludmerer SW, Jumes PA, Marshall WL, Kong S, Ingravallo P, Black S, Pak I, DiNubile MJ, Howe AY. Susceptibilities of genotype 1a, 1b, and 3 hepatitis C virus variants to the NS5A inhibitor elbasvir. Antimicrob Agents Chemother. 2015 Nov;59(11):6922-9. doi: 10.1128/AAC.01390-15. Epub 2015 Aug 24.
Results publication: PubMed 29703432Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25.

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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 1 study testing Elbasvir in people with Hepatitis, Viral, Human, 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 3 inclusion and 11 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 17 Jul 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 (time frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5). The study lists 8 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 NCT01532973, which also lists 2 linked publications.

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 2018.