Chronic Hepatitis C InfectionPhase 1NCT01700179

Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

A Phase 1 study testing ACH-0143102 and Ribavirin in people with Chronic Hepatitis C Infection, run by Alexion Pharmaceuticals, Inc..

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 was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C Infection
What is being tested?: ACH-0143102 and Ribavirin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: No sites listed yet
Study dates: Sep 2012to Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females aged 18 years and older.
Clinical diagnosis of hepatitis C with GT1b.
Chronic hepatitis C treatment-naive participants.
Interleukin 28B genotype CC.
HCV ribonucleic acid > 10,000 international units/milliliter at screening.
Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin.
Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin.
Willing to participate in all study activities and all study requirements.

Who cannot join

Body mass index > 36 kilograms/meter squared.
Pregnant or nursing females.
Clinically significant laboratory abnormalities at screening.
Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
Human immunodeficiency virus infection or other liver diseases.
Positive hepatitis B surface antigen.

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Liver cirrhosis.
Uncontrolled psychiatric disease.
Clinical evidence of chronic cardiac disease.
History of malignancy of any organ system within 5 years.

About this study

Official title: A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment-naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b

Read the detailed description

A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.

Conditions: Chronic Hepatitis C Infection
Being tested: ACH-0143102, Ribavirin

What participants receive

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

ACH-0143102Drug
RibavirinDrug

Study groups in NCT01700179
Study group	Role	What they receive
ACH-0143102 plus ribavirin daily	Experimental	ACH-0143102 loading dose (225 milligrams [mg]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84. Receives: Drug: ACH-0143102; Drug: Ribavirin

What is being measured

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

Sustained Virologic Response At 12 Weeks (SVR12)
To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.
Measured: 12 weeks following the last dose

Timeline

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

Sep 2012Sep 2013

First posted4 Oct 2012 (estimated)
Study startSep 2012
Primary completionSep 2013
Study completionSep 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.
Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
More trials run by Alexion Pharmaceuticals, Inc.The 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01700179
Sponsor's protocol ID: ACH102-005
Status last verified: Aug 2023
First submitted: 2 Oct 2012
Last updated: 29 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
Hepatitis D, Hepatitis C
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 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment-naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b
ClinicalTrials.gov ID: NCT01700179
Acronym / sponsor ID: ACH102-005
Conditions: Chronic Hepatitis C Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Achillion, a wholly owned subsidiary of Alexion
Study start: Sep 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 4 Oct 2012 (estimated)
Results: Posted 3 Oct 2014

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ACH-0143102 plus ribavirin daily	Experimental	Drug: ACH-0143102, Drug: RibavirinACH-0143102 loading dose (225 milligrams [mg]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.

Who may qualify

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

Key inclusion criteria (8 listed)

Males and females aged 18 years and older.
Clinical diagnosis of hepatitis C with GT1b.
Chronic hepatitis C treatment-naive participants.
Interleukin 28B genotype CC.
HCV ribonucleic acid > 10,000 international units/milliliter at screening.

Key exclusion criteria (10 listed)

Body mass index > 36 kilograms/meter squared.
Pregnant or nursing females.
Clinically significant laboratory abnormalities at screening.
Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
Human immunodeficiency virus infection or other liver diseases.

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
ACH-0143102	Drug	ACH-0143102 plus ribavirin daily
Ribavirin	Drug	ACH-0143102 plus ribavirin daily

Primary outcome

Sustained Virologic Response At 12 Weeks (SVR12)
Time frame: 12 weeks following the last dose
To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.

Results and safety

Results posted to the registry on 3 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACH-0143102 Plus Ribavirin	8	6

Primary outcome: Sustained Virologic Response At 12 Weeks (SVR12)

Time frame: 12 weeks following the last dose. Number. Unit: percentage of participants

Measure	ACH-0143102 Plus Ribavirin n = 8
Value	50

Adverse events

Time frame: Adverse event data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up, for up to 36 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACH-0143102 Plus Ribavirin	0 of 8 (0%)	6 of 8 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Hepatitis C Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACH-0143102 and Ribavirin in people with Chronic Hepatitis C Infection, run by Alexion Pharmaceuticals, Inc..

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 8 inclusion and 10 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 29 Aug 2023. 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 3 Oct 2014). 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?

Sustained Virologic Response At 12 Weeks (SVR12) (time frame: 12 weeks following the last dose). 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 NCT01700179.

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 29 Aug 2023.