NCT02455167

Brief Summary

  1. 1.Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).
  2. 2.Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2016

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

September 13, 2021

Completed
Last Updated

September 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

April 21, 2015

Results QC Date

August 16, 2021

Last Update Submit

August 16, 2021

Conditions

Hepatitis C

Keywords

HCVHepatitis C

Outcome Measures

Primary Outcomes (3)

  • The Sustained Virologic Response (SVR) in Patients Infected With HCV Genotype 1, Cirrhosis, and Early Clinical Decompensation

    Number of participants who cleared Hepatitis C (HCV) after 12 weeks was collected (HCV RNA level was "Not Detected".

    12 weeks

  • Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: Baseline

    Liver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome.

    Baseline

  • Hepatic Improvement During and After Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) Treatment Using a New Test of Liver Function, HepQuant-SHUNT: 12 Weeks

    Liver function as assessed via MELD score. The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome.

    12 Weeks

Study Arms (1)

HCV positive group

EXPERIMENTAL

A single arm study of 'Simeprivir (SMV), Sofosbuvir (SOF) and Ribavirin (RBV) in an HCV positive population.

Drug: Simeprivir (SMV)Drug: Sofosbuvir (SOF)Drug: Ribavirin (RBV)

Interventions

Simeprivir (SMV)DRUG

Experimental Single arm study. All participants will get the same treatment.

Also known as: Olysio (Simeprivir);
HCV positive group
Sofosbuvir (SOF)DRUG

Experimental Single arm study. All participants will get the same treatment.

Also known as: Solvaldi (Sofosbuvir);
HCV positive group
Ribavirin (RBV)DRUG

Experimental Single arm study. All participants will get the same treatment.

Also known as: Virazole (Ribavirin);
HCV positive group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV genotype 1 infection (all subtypes and Q80K a type of mutation are allowed), and have been approved by a third party payer for the FDA-approved combination of sofosbuvir (SOF) plus ribavirin. The study drug, simeprevir (SMV)
  • Biopsy proven cirrhosis, or clinical cirrhosis with APRI (AST to Platelet Ratio Index to determine clinical cirrhosis)\> 2, Fibrotest \> 0.75, or Fibroscan \> 12.5 Results Stiffness (kPa).
  • MELD 10 or less
  • Expected survival without liver transplantation of \>1 year
  • Patients with Hepatocellular carcinoma (HCC) are included as long as disease MELD is 10 or less, and anticipated time to transplant is \>1 year. An example, might be a patient with a subcentimeter HCC who is undergoing serial imaging to document tumor growth to tumor diameter \>2 cm prior to listing for transplantation (in order to secure MELD exception). In this case, there could be a time lapse of 3 months or more while monitoring tumor growth, and a further time lapse of 9 months or more until the time of transplantation.
  • Patients with TIPS or Portal Vein Thrombosis may be included. -

You may not qualify if:

  • Inability to provide informed consent
  • Known hypersensitivity or serious adverse reaction to any of the study drugs
  • Age \<18 or \>80 years
  • Pregnancy as determined by subject reporting and urine dipstick testing at screening.
  • Other underlying chronic liver disease - examples that would exclude a patient from participating include but are not limited to nonalcoholic liver disease, alcoholic liver disease, hepatitis B, hemochromatosis, and autoimmune liver disease.
  • Serious other underlying medical condition - examples include but are not limited to unstable cardiovascular, coronary, or pulmonary disease including right and left sided heart failure, active malignancy other than HCC, or serious infection.
  • Estimated creatinine clearance \< 30 mL min-1 1.73 m2 surface area (BSA)
  • Hemoglobin \<10 g/dL
  • Neutrophils \<500 /μL
  • Platelets \<50,000 /μL
  • Bilirubin \>4 mg/dL
  • Albumin \< 2.8 g/dL
  • Blood Clotting: International Normalised Ratio (INR) \> 2
  • MELD \>10
  • Child-Turcotte-Pugh class B or C; or, CTP score \>7
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver (Leprino Building)

Denver, Colorado, 80045, United States

Location

Related Publications (7)

  • Everson GT, Martucci MA, Shiffman ML, Sterling RK, Morgan TR, Hoefs JC; HALT-C trial group. Portal-systemic shunting in patients with fibrosis or cirrhosis due to chronic hepatitis C: the minimal model for measuring cholate clearances and shunt. Aliment Pharmacol Ther. 2007 Aug 1;26(3):401-10. doi: 10.1111/j.1365-2036.2007.03389.x.

    PMID: 17635375RESULT

  • Everson GT, Shiffman ML, Morgan TR, Hoefs JC, Sterling RK, Wagner DA, Kulig CC, Curto TM, Wright EC; Halt-C Trial Group. The spectrum of hepatic functional impairment in compensated chronic hepatitis C: results from the Hepatitis C Anti-viral Long-term Treatment against Cirrhosis Trial. Aliment Pharmacol Ther. 2008 May;27(9):798-809. doi: 10.1111/j.1365-2036.2008.03639.x. Epub 2008 Feb 7.

    PMID: 18266997RESULT

  • Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Desanto JL, Curto TM, Wright EC; HALT-C Trial Group. Quantitative tests of liver function measure hepatic improvement after sustained virological response: results from the HALT-C trial. Aliment Pharmacol Ther. 2009 Mar 1;29(5):589-601. doi: 10.1111/j.1365-2036.2008.03908.x. Epub 2008 Dec 1.

    PMID: 19053983RESULT

  • Everson GT. Hepatic cysts in autosomal dominant polycystic kidney disease. Am J Kidney Dis. 1993 Oct;22(4):520-5. doi: 10.1016/s0272-6386(12)80923-1. No abstract available.

    PMID: 8213790RESULT

  • Shrestha R, McKinley C, Showalter R, Wilner K, Marsano L, Vivian B, Everson GT. Quantitative liver function tests define the functional severity of liver disease in early-stage cirrhosis. Liver Transpl Surg. 1997 Mar;3(2):166-73. doi: 10.1002/lt.500030210.

    PMID: 9346731RESULT

  • Shaheen AA, Wan AF, Myers RP. FibroTest and FibroScan for the prediction of hepatitis C-related fibrosis: a systematic review of diagnostic test accuracy. Am J Gastroenterol. 2007 Nov;102(11):2589-600. doi: 10.1111/j.1572-0241.2007.01466.x. Epub 2007 Sep 10.

    PMID: 17850410RESULT

  • Tripodi A, Caldwell SH, Hoffman M, Trotter JF, Sanyal AJ. Review article: the prothrombin time test as a measure of bleeding risk and prognosis in liver disease. Aliment Pharmacol Ther. 2007 Jul 15;26(2):141-8. doi: 10.1111/j.1365-2036.2007.03369.x.

    PMID: 17593061RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

SimeprevirSofosbuvirRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsUridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Results Point of Contact

Title
Amanda Wieland, MD
Organization
University of Colorado Denver | Anschutz
clinicalresearchsupportcenter@ucdenver.edu
3037241111

Study Officials

  • Amanda Wieland, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

July 18, 2016

Study Completion

July 18, 2016

Last Updated

September 13, 2021

Results First Posted

September 13, 2021

Record last verified: 2021-08

Locations

US(1)