NCT03296930

Brief Summary

The aim of the study is to determine the effect of different direct acting antiviral drugs used for treatment of chronic HCV infected patients on normal kidney.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_4

Status
unknown

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

September 16, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

12 months

First QC Date

September 16, 2017

Last Update Submit

September 26, 2017

Conditions

Antiviral Drug Adverse Reaction

Keywords

Direct Acting Antiviral Agents (DAAs)

Outcome Measures

Primary Outcomes (1)

  • Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine.

    assessment of the renal toxicity of direct acting antivirals used for HCV treatment by measurement of the serum creatinine to detect any deviation beyond the normal values.

    one year

Study Arms (2)

first drug group

ACTIVE COMPARATOR

Sofosbuvir 400 MG Oral Tablet

Drug: Sofosbuvir 400 MG Oral Tablet,

second drug group

ACTIVE COMPARATOR

Ombitasvir/paritaprevir/ritonavir

Drug: Ombitasvir/paritaprevir/ritonavir

Interventions

Sofosbuvir 400 MG Oral Tablet,DRUG

Interferon free direct acting antiviral drugs used for treatment of HCV.

Also known as: daclatasvir, ribavirin
first drug group
Ombitasvir/paritaprevir/ritonavirDRUG

Interferon free direct acting antiviral drugs used for treatment of HCV.

Also known as: ribavirin
second drug group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female patients with age above 18 years presented with chronic HCV infection (diagnosed by HCV RNA positive) with normal kidney functions, i.e.:
  • Normal S.creatinine
  • Normal urine analysis (without proteinuria, haematuria or abnormal casts).
  • Normal renal sonography.
  • and candidate for direct acting antiviral drugs.

You may not qualify if:

  • Any chronic HCV patient with known renal disease.
  • Patients with abnormal kidney functions, i.e.:
  • Abnormal S.creatinine.
  • Abnormal urine analysis (with proteinuria, haematuria or abnormal casts).
  • Abnormal renal US
  • Any other known renal disease (lupus nephritis, diabetic nephropathy).
  • Severe co-morbidity as severe heart failure or malignancy.
  • Other liver disease (autoimmune hepatitis, HBV, Wilson, ……).
  • Decompansated liver disease (ascites, hepatic encephalopathy, …).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Behnava B, Sharafi H, Keshvari M, Pouryasin A, Mehrnoush L, Salimi S, Karimi Elizee P, Ghazimoghaddam M, Alavian SM. The Role of Polymorphisms Near the IL28B Gene on Response to Peg-Interferon and Ribavirin in Thalassemic Patients With Hepatitis C. Hepat Mon. 2016 Jan 23;16(1):e32703. doi: 10.5812/hepatmon.32703. eCollection 2016 Jan.

    PMID: 27110259BACKGROUND

  • Cacoub P, Gragnani L, Comarmond C, Zignego AL. Extrahepatic manifestations of chronic hepatitis C virus infection. Dig Liver Dis. 2014 Dec 15;46 Suppl 5:S165-73. doi: 10.1016/j.dld.2014.10.005. Epub 2014 Nov 8.

    PMID: 25458776BACKGROUND

  • Carrier P, Essig M, Debette-Gratien M, Sautereau D, Rousseau A, Marquet P, Jacques J, Loustaud-Ratti V. Anti-hepatitis C virus drugs and kidney. World J Hepatol. 2016 Nov 18;8(32):1343-1353. doi: 10.4254/wjh.v8.i32.1343.

    PMID: 27917261BACKGROUND

  • European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. No abstract available.

    PMID: 25911336BACKGROUND

  • Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR; PEARL-III Study; PEARL-IV Study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.

    PMID: 24795200BACKGROUND

  • Haj-Sheykholeslami A, Keshvari M, Sharafi H, Pouryasin A, Hemmati K, Mohammadzadehparjikolaei F. Interferon-lambda polymorphisms and response to pegylated interferon in Iranian hepatitis C patients. World J Gastroenterol. 2015 Aug 7;21(29):8935-42. doi: 10.3748/wjg.v21.i29.8935.

    PMID: 26269684BACKGROUND

  • Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Rojter S, Schiff E, Davis M, Ruane P, Younes Z, Kalmeijer R, Sinha R, Peeters M, Lenz O, Fevery B, De La Rosa G, Scott J, Witek J. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology. 2016 Aug;64(2):370-80. doi: 10.1002/hep.28467. Epub 2016 Mar 22.

    PMID: 26799692BACKGROUND

  • Lee SS, Bain VG, Peltekian K, Krajden M, Yoshida EM, Deschenes M, Heathcote J, Bailey RJ, Simonyi S, Sherman M; CANADIAN PEGASYS STUDY GROUP. Treating chronic hepatitis C with pegylated interferon alfa-2a (40 KD) and ribavirin in clinical practice. Aliment Pharmacol Ther. 2006 Feb 1;23(3):397-408. doi: 10.1111/j.1365-2036.2006.02748.x.

    PMID: 16422999BACKGROUND

  • Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.

    PMID: 11583749BACKGROUND

  • Pawlotsky JM. New hepatitis C therapies: the toolbox, strategies, and challenges. Gastroenterology. 2014 May;146(5):1176-92. doi: 10.1053/j.gastro.2014.03.003. Epub 2014 Mar 12.

    PMID: 24631495BACKGROUND

  • Sharafi H, Alavian SM. IL28B polymorphism, Explanation for Different Responses to Therapy in Hepatitis C Patients. Hepat Mon. 2011 Dec;11(12):958-9. doi: 10.5812/kowsar.1735143X.794. Epub 2011 Dec 20. No abstract available.

    PMID: 22368678BACKGROUND

  • Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218.

    PMID: 24428467BACKGROUND

  • Tong MJ, Reddy KR, Lee WM, Pockros PJ, Hoefs JC, Keeffe EB, Hollinger FB, Hathcote EJ, White H, Foust RT, Jensen DM, Krawitt EL, Fromm H, Black M, Blatt LM, Klein M, Lubina J. Treatment of chronic hepatitis C with consensus interferon: a multicenter, randomized, controlled trial. Consensus Interferon Study Group. Hepatology. 1997 Sep;26(3):747-54. doi: 10.1002/hep.510260330.

    PMID: 9303508BACKGROUND

  • Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ben Ari Z, Zhao Y, Brown DD, Wan S, DiNubile MJ, Nguyen BY, Robertson MN, Wahl J, Barr E, Butterton JR. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015 Jul 7;163(1):1-13. doi: 10.7326/M15-0785.

    PMID: 25909356BACKGROUND

MeSH Terms

Interventions

SofosbuvirTabletsdaclatasvirRibavirinombitasvir

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesDosage FormsPharmaceutical PreparationsRibonucleosidesNucleosides

Study Officials

  • Zainelabdeen A Sayed, MD

    Assistant Professor of Internal Medicine

    STUDY CHAIR

  • Mohammed M Abdallah, MD

    Professor of Internal Medicine

    STUDY CHAIR

Central Study Contacts

Hazem Y Shouman, M.B.B.Ch

CONTACT

+201111114746dr.hazem.shoman1@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 16, 2017

First Posted

September 29, 2017

Study Start

October 1, 2017

Primary Completion

September 30, 2018

Study Completion

October 31, 2018

Last Updated

September 29, 2017

Record last verified: 2017-09