Hepatitis C InfectionNCT01771653

Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection

An observational study of Hepatitis C Infection, run by Southern Illinois University at 1 site in United States.

Completed

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

Trial summary

The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Hepatitis C Infection
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Jul 2015
Phase: Observational
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 64 years
All sexes
No healthy volunteers
Adult

Study population: Population of adults aged 18-64 years, diagnosed with HCV genotype 1, with an HCV RNA >100,000. They should have had a liver biopsy within 5 years before enrollment. Lab work to determine eligibility includes an absolute neutrophil count of at least 1200 per cubic millimeter, a platelet count of at least 90,000 per cubic millimeter and a hemoglobin level of at least 12 g per deciliter

Who may be able to join

Age - 18-64 years
HCV genotype 1
HCV RNA >100,000
Liver biopsy within 5 years before enrollment
Absolute neutrophil count of at least 1200 per cubic millimeter
Platelet count of at least 90,000 per cubic millimeter
Hemoglobin level of at least 12 g per deciliter
Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) forms

Who cannot join

HCV genotypes other than genotype 1
Immunocompromised conditions including HIV, transplant or immunosuppressive drugs
Decompensated liver disease or hepatocellular carcinoma
Any other types of active cancer
Active autoimmune disorders
Major psychiatric disorders

Show all 10Show fewer

Active drug or alcohol use
Pregnancy or lactation
Patients with allergy to any of the drugs used in this study
Drugs that may interact with boceprevir or telaprevir as listed in the package insert

Trial locations and contacts

1 site in 1 country.

United States1 site

Southern Illinois University School of Medicine
Springfield, Illinois, 62701

Other trials in United States

About this study

The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C.

Read the detailed description

The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV) protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data will be obtained from medical records of consenting patients.

Conditions: Hepatitis C Infection
Keywords: Hepatitis C infection, Hepatitis C Virus, HCV
Medical subject headings: Hepatitis C

What participants receive

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

Study groups in NCT01771653
Study group	Role	What they receive
Previously treated		Data from patients who were previously treated with Peg, interferon (IFN), alfa, and ribavirin
Previously untreated		Records of patients who have never received anti-HCV treatment.

What is being measured

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

Virologic Response
Sustained Virologic Response (SVR) rates will be compared between the two arms of treatment through measured HCV RNA levels after 24 weeks, 48 weeks and 96 weeks after completion of treatment.
Measured: up to 96 weeks post treatment

Secondary outcomes (2)

Adverse events
Comparison of rates and severity of adverse events between the two study arms
Measured: 24, 48, and 96 weeks post treatment
Effect of baseline variables on treatment outcome
Analyze the effects of baseline variables on treatment outcome between the two groups- age, race, social economic status.
Measured: 24, 48, and 96 weeks post treatment

Timeline

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

Sep 2011Jul 2015

First posted18 Jan 2013 (estimated)
Study startSep 2011
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Hepatitis C InfectionStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01771653
Sponsor's protocol ID: KOI-SIUSOM-12-002
Status last verified: Jan 2016
First submitted: 16 Jan 2013
Last updated: 18 Jan 2016
Results posted: No
Data monitoring committee: No

Publications

Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
PubMed 11439948
Di Bisceglie AM, Lyra AC, Schwartz M, Reddy RK, Martin P, Gores G, Lok AS, Hussain KB, Gish R, Van Thiel DH, Younossi Z, Tong M, Hassanein T, Balart L, Fleckenstein J, Flamm S, Blei A, Befeler AS; Liver Cancer Network. Hepatitis C-related hepatocellular carcinoma in the United States: influence of ethnic status. Am J Gastroenterol. 2003 Sep;98(9):2060-3. doi: 10.1111/j.1572-0241.2003.t01-1-07641.x.
PubMed 14499788
Witthoeft T, Hueppe D, John C, Goelz J, Heyne R, Moeller B, Teuber G, Wollschlaeger S, Baumgarten A, Simon KG, Moog G, Dikopoulos N, Mauss S. Efficacy and tolerability of peginterferon alfa-2a or alfa-2b plus ribavirin in the daily routine treatment of patients with chronic hepatitis C in Germany: the PRACTICE study. J Viral Hepat. 2010 Jul;17(7):459-68. doi: 10.1111/j.1365-2893.2009.01255.x. Epub 2010 Feb 11.
PubMed 20158603
O'Brien TR, Everhart JE, Morgan TR, Lok AS, Chung RT, Shao Y, Shiffman ML, Dotrang M, Sninsky JJ, Bonkovsky HL, Pfeiffer RM; HALT-C Trial Group. An IL28B genotype-based clinical prediction model for treatment of chronic hepatitis C. PLoS One. 2011;6(7):e20904. doi: 10.1371/journal.pone.0020904. Epub 2011 Jul 8.
PubMed 21760886
Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.
PubMed 21449783
Koirala J, Gandotra SD, Rao S, Sangwan G, Mushtaq A, Htwe TH, Adamski A, Blessman D, Khardori NM. Granulocyte colony-stimulating factor dosing in pegylated interferon alpha-induced neutropenia and its impact on outcome of anti-HCV therapy. J Viral Hepat. 2007 Nov;14(11):782-7. doi: 10.1111/j.1365-2893.2007.00870.x.
PubMed 17927614
Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17. doi: 10.1056/NEJMoa1009482.
PubMed 21449784
Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.
PubMed 21696307
Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.
PubMed 21696308
McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.
PubMed 20375406

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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All Hepatitis C Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT01771653
Acronym / sponsor ID: KOI-SIUSOM-12-002
Conditions: Hepatitis C Infection
Keywords: Hepatitis C infection, Hepatitis C Virus, HCV
Study type: Observational
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Southern Illinois UniversityUniversity, hospital or other
Study start: Sep 2011
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 18 Jan 2013 (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.

The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Previously treated	–	–Data from patients who were previously treated with Peg, interferon (IFN), alfa, and ribavirin
Previously untreated	–	–Records of patients who have never received anti-HCV treatment.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Population of adults aged 18-64 years, diagnosed with HCV genotype 1, with an HCV RNA >100,000. They should have had a liver biopsy within 5 years before enrollment. Lab work to determine eligibility includes an absolute neutrophil count of at least 1200 per cubic millimeter, a platelet count of at least 90,000 per cubic millimeter and a hemoglobin level of at least 12 g per deciliter

Key inclusion criteria (8 listed)

Age - 18-64 years
HCV genotype 1
HCV RNA >100,000
Liver biopsy within 5 years before enrollment
Absolute neutrophil count of at least 1200 per cubic millimeter

Key exclusion criteria (10 listed)

HCV genotypes other than genotype 1
Immunocompromised conditions including HIV, transplant or immunosuppressive drugs
Decompensated liver disease or hepatocellular carcinoma
Any other types of active cancer
Active autoimmune disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Virologic Response
Time frame: up to 96 weeks post treatment
Sustained Virologic Response (SVR) rates will be compared between the two arms of treatment through measured HCV RNA levels after 24 weeks, 48 weeks and 96 weeks after completion of treatment.

2 secondary outcomes

Adverse events
Time frame: 24, 48, and 96 weeks post treatment
Effect of baseline variables on treatment outcome
Time frame: 24, 48, and 96 weeks post treatment

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 18 Jan 2016.
Background: PubMed 11439948Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
Background: PubMed 14499788Di Bisceglie AM, Lyra AC, Schwartz M, Reddy RK, Martin P, Gores G, Lok AS, Hussain KB, Gish R, Van Thiel DH, Younossi Z, Tong M, Hassanein T, Balart L, Fleckenstein J, Flamm S, Blei A, Befeler AS; Liver Cancer Network. Hepatitis C-related hepatocellular carcinoma in the United States: influence of ethnic status. Am J Gastroenterol. 2003 Sep;98(9):2060-3. doi: 10.1111/j.1572-0241.2003.t01-1-07641.x.
Background: PubMed 20158603Witthoeft T, Hueppe D, John C, Goelz J, Heyne R, Moeller B, Teuber G, Wollschlaeger S, Baumgarten A, Simon KG, Moog G, Dikopoulos N, Mauss S. Efficacy and tolerability of peginterferon alfa-2a or alfa-2b plus ribavirin in the daily routine treatment of patients with chronic hepatitis C in Germany: the PRACTICE study. J Viral Hepat. 2010 Jul;17(7):459-68. doi: 10.1111/j.1365-2893.2009.01255.x. Epub 2010 Feb 11.
Background: PubMed 21760886O'Brien TR, Everhart JE, Morgan TR, Lok AS, Chung RT, Shao Y, Shiffman ML, Dotrang M, Sninsky JJ, Bonkovsky HL, Pfeiffer RM; HALT-C Trial Group. An IL28B genotype-based clinical prediction model for treatment of chronic hepatitis C. PLoS One. 2011;6(7):e20904. doi: 10.1371/journal.pone.0020904. Epub 2011 Jul 8.
Background: PubMed 21449783Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.
Background: PubMed 17927614Koirala J, Gandotra SD, Rao S, Sangwan G, Mushtaq A, Htwe TH, Adamski A, Blessman D, Khardori NM. Granulocyte colony-stimulating factor dosing in pegylated interferon alpha-induced neutropenia and its impact on outcome of anti-HCV therapy. J Viral Hepat. 2007 Nov;14(11):782-7. doi: 10.1111/j.1365-2893.2007.00870.x.
Background: PubMed 21449784Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17. doi: 10.1056/NEJMoa1009482.
Background: PubMed 21696307Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.
Background: PubMed 21696308Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.
Background: PubMed 20375406McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.
telaprevir prescribing informationLink provided by the sponsor.

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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.

Janak Koirala, MD, MPH principal investigator

Southern Illinois University School of Medicine

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Infection, run by Southern Illinois University 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 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 18 Jan 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.

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?

Virologic Response (time frame: up to 96 weeks post treatment). 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 NCT01771653, which also lists 10 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 18 Jan 2016.