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Hepatitis CPhase 2NCT02278419

An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection

A Phase 2 study testing Simeprevir and Sofosbuvir in people with Hepatitis C, run by Janssen-Cilag International NV at 2 sites in Egypt.

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 the efficacy of simeprevir in combination with sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in the overall population. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis C
What is being tested?
Simeprevir and Sofosbuvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
2 sitesEgypt
Study dates
Dec 2014to Oct 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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must have hepatitis C virus (HCV) genotype 4 infection (confirmed at screening)
  • Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL) at screening
  • In participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [CT] scan, or magnetic resonance imaging [MRI]) within 6 months before baseline (Day 1) to exclude hepatocellular carcinoma is required
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on Day 1 before first dose of study drug
  • Females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from Day 1 (baseline) and continue until 30 days after the end of treatment (EOT) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)

Who cannot join

  • Participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
  • Participant has any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator
  • Participant is infected/co-infected with non-genotype 4 HCV
  • Participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ECG) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
  • Participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • Study site

    Cairo

  • Study site

    Menoufiya

Other trials in Egypt

About this study

Official title: A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infection

The purpose of this study is to evaluate the efficacy of simeprevir in combination with sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in the overall population.

Read the detailed description

This is a partly randomized, open-label (identity of study drug will be known to volunteer and study staff), multicenter (when more than one hospital or medical school team work on a medical research study) study. The study will consist of a screening period of up to 4 weeks, an open-label treatment period of 8 weeks or 12 weeks, and a post-treatment follow-up period until 24 weeks after end of treatment (EOT). Participants without cirrhosis will be assigned to Group A wherein half of the participants will receive 8 week treatment in Group A1 and remaining participants will receive 12 week treatment in Group A2. Participants with cirrhosis, will be assigned to Group B to receive simeprevir in combination with sofosbuvir for 12 weeks. The duration of participation for each participant, including the screening period, will be approximately 36 or 40 weeks for 8 or 12 week treatment, respectively. Efficacy will be primarily assessed by percentage of participants with SVR12. Participants' safety will be evaluated throughout the study.

Conditions
Hepatitis C
Being tested
Simeprevir, Sofosbuvir
Keywords
Hepatitis C, Simeprevir, Sofosbuvir, Healthy
Medical subject headings
Hepatitis C

What participants receive

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

  • SimeprevirDrug

    Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.

  • SofosbuvirDrug

    Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.

Study groups in NCT02278419
Study groupRoleWhat they receive
Group A1ExperimentalParticipants without cirrhosis will receive simeprevir 150 milligram (mg) capsule along with sofosbuvir 400 mg tablet, orally, once daily for 8 weeks.
Receives: Drug: Simeprevir; Drug: Sofosbuvir
Group A2ExperimentalParticipants without cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.
Receives: Drug: Simeprevir; Drug: Sofosbuvir
Group BExperimentalParticipants with cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.
Receives: Drug: Simeprevir; Drug: Sofosbuvir

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)

    SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]), detectable or undetectable at 12 weeks after EOT.

    Measured: 12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

Secondary outcomes (6)

  1. Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)

    SVR4 is defined as HCV RNA <LLOQ;15 IU/mL, at 4 weeks after EOT.

    Measured: 4 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

  2. Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)

    SVR24 is defined as HCV RNA <LLOQ;15 IU/mL, at 24 weeks after EOT.

    Measured: 24 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

  3. Percentage of Participants With on-treatment Failure

    Participants will be considered on-treatment failures if they have (confirmed) detectable HCV RNA, that is <LLOQ;15 IU/mL, detectable or greater than or equal to (>=) LLOQ at EOT.

    Measured: EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)

  4. Percentage of Participants With Viral Relapse

    Participants will be considered to have viral relapse if they do not achieve SVR at Week 4, 12 and 24 after EOT and meet the following conditions 1) HCV RNA <LLOQ;15 IU/mL, undetectable at EOT, 2) HCV RNA >=LLOQ;15 IU/mL during the follow-up period.

    Measured: EOT (Week 8 for Group A1, Week 12 for Group A2 and Group B), Weeks 4, 12 and 24 after end of treatment

  5. Percentage of Participants With On-treatment Response

    On-treatment virologic response is defined as the change from baseline in log10 hepatitis C virus ribonucleic acid.

    Measured: Week 1, 2, 4, 8 and EOT for all groups, Week 12 for Group A2 and Group B

  6. Percentage of Participants With Viral Breakthrough

    Viral breakthrough is defined as confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ; 15 IU/mL.

    Measured: Week 1 up to Week 8 in Group A1, Week 1 up to Week 12 in Group A2 and Group B

Timeline

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

  1. First posted30 Oct 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02278419
Sponsor's protocol ID
CR104970
Other IDs
TMC435HPC2014
Status last verified
Sep 2016
First submitted
28 Oct 2014
Last updated
14 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • El Raziky M, Gamil M, Ashour MK, Sameea EA, Doss W, Hamada Y, Van Dooren G, DeMasi R, Keim S, Lonjon-Domanec I, Hammad R, Hashim MS, Hassany M, Waked I. Simeprevir plus sofosbuvir for eight or 12 weeks in treatment-naive and treatment-experienced hepatitis C virus genotype 4 patients with or without cirrhosis. J Viral Hepat. 2017 Feb;24(2):102-110. doi: 10.1111/jvh.12625. Epub 2016 Oct 27.

    PubMed 27790789

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Simeprevir and Sofosbuvir in people with Hepatitis C, run by Janssen-Cilag International NV at 2 sites in Egypt.

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

Where is the study taking place?

The record lists 2 sites in Egypt. 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 at Week 12 After End of Treatment (SVR12) (time frame: 12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)). 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 NCT02278419, 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 14 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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