Chronic Hepatitis CPhase 4NCT02168361

The SIM-SOF Trial for Hepatitis C

A Phase 4 study testing Pegylated Interferon alfa-2b, Simeprevir and Ribavirin in people with Chronic Hepatitis C, run by Center For Hepatitis C, Atlanta, GA at 1 site 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

Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C
What is being tested?: Pegylated Interferon alfa-2b, Simeprevir and Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Apr 2015
Phase: Phase 4
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

chronic hepatitis c,
cirrhosis biopsy-proven, or via fibrotest,
CPT score less than 7,
genotype 1a,
INR 2.3 or less,
serum albumin greater than 2.7 gm/dL,

Show all 9Show fewer

total bilirubin less than 3 gm/dL,
platelet count 50,000 per cubic milliliter or more
GFR >50 ml/min

Who cannot join

non genotype 1a,
history of CPT class B or C or decompensation or history of same,
HIV or HBV coinfection,
prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,
uncontrolled psychiatric or cardiopulmonary disorders,
planning pregnancy or unwilling/unable to practice contraception

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Hepatitis C
Atlanta, Georgia, 30309

Other trials in United States

About this study

Official title: The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis

Read the detailed description

Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Conditions: Chronic Hepatitis C
Being tested: Pegylated Interferon alfa-2b, Simeprevir, Ribavirin, Sofosbuvir
Keywords: cirrhosis
Medical subject headings: Hepatitis C, Chronic, Fibrosis

What participants receive

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

Pegylated Interferon alfa-2bDrug
Also called Pegintron
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
SimeprevirDrug
Also called Olysio
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
RibavirinDrug
Also called Ribavirin Ribasphere Ribapak
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
SofosbuvirDrug
Also called Sovaldi
12 weeks of combination sofosbuvir and simeprevir

Study groups in NCT02168361
Study group	Role	What they receive
Standard	Active comparator	Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks Receives: Drug: Pegylated Interferon alfa-2b; Drug: Ribavirin; Drug: Sofosbuvir
Simeprevir + Sofosbuvir	Experimental	(SIM-SOF) which is Simeprevir + Sofosbuvir 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.

Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
Measured: 12 weeks post-therapy

Secondary outcomes (1)

Serum HCV RNA Level
Measured: 4 and 12 weeks into therapy

Timeline

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

Dec 2013Apr 2015

First posted20 Jun 2014 (estimated)
Study startDec 2013
Primary completionDec 2014
Study completionApr 2015

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 (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02168361
Sponsor's protocol ID: CHC-21
Status last verified: Mar 2016
First submitted: 17 Jun 2014
Last updated: 14 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.
PubMed 25557952

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?

See locations

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"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis
ClinicalTrials.gov ID: NCT02168361
Acronym / sponsor ID: CHC-21
Conditions: Chronic Hepatitis C
Keywords: cirrhosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Center For Hepatitis C, Atlanta, GAUniversity, hospital or other
Study start: Dec 2013
Primary completion: Dec 2014 (actual)
Study completion: Apr 2015 (actual)
First posted: 20 Jun 2014 (estimated)
Results: Posted 4 Mar 2016

Clinical summary

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

Detailed description

Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard	Active comparator	Drug: Pegylated Interferon alfa-2b, Drug: Ribavirin, Drug: SofosbuvirPegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks
Simeprevir + Sofosbuvir	Experimental	Drug: Simeprevir, Drug: Sofosbuvir(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks

Who may qualify

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

Key inclusion criteria (9 listed)

chronic hepatitis c,
cirrhosis biopsy-proven, or via fibrotest,
CPT score less than 7,
genotype 1a,
INR 2.3 or less,

Key exclusion criteria (6 listed)

non genotype 1a,
history of CPT class B or C or decompensation or history of same,
HIV or HBV coinfection,
prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,
uncontrolled psychiatric or cardiopulmonary disorders,

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
Pegylated Interferon alfa-2bAlso: Pegintron1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total	Drug	Standard
SimeprevirAlso: Olysio150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks	Drug	Simeprevir + Sofosbuvir
RibavirinAlso: Ribavirin Ribasphere Ribapak1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir	Drug	Standard
SofosbuvirAlso: Sovaldi12 weeks of combination sofosbuvir and simeprevir	Drug	Simeprevir + Sofosbuvir, Standard

Primary outcome

Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
Time frame: 12 weeks post-therapy
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy

1 secondary outcome

Serum HCV RNA Level
Time frame: 4 and 12 weeks into therapy

Results and safety

Results posted to the registry on 4 Mar 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
All Oral Therapy	62	57
Interferon-containing Arm	31	21

Primary outcome: Proportion of Participants With Sustained Virologic Response 12 (SVR-12)

Time frame: 12 weeks post-therapy. Number. Unit: participants

Measure	All Oral Therapy n = 58	Interferon-containing Arm n = 24
Value	54	18

All Oral Therapy vs Interferon-containing Arm: p = .02, Chi-squared

Population analysed: All participants that received at least a single dose of medication

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Oral	0 of 58 (0%)	46 of 58 (79.3%)	Not reported
Interferon-containing	1 of 24 (4.2%)	22 of 24 (91.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25557952Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.

Related trials for Chronic Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
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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
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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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.

Brian L Pearlman, MD principal investigator

Center for Hepatitis C

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pegylated Interferon alfa-2b, Simeprevir and Ribavirin in people with Chronic Hepatitis C, run by Center For Hepatitis C, Atlanta, GA at 1 site 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 9 inclusion and 6 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 4 Mar 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?

Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (time frame: 12 weeks post-therapy). 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 NCT02168361, 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 Mar 2016.