AzTrials
AzTrials

Hepatitis C, ChronicPhase 3NCT00516321

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease

A Phase 3 study testing eltrombopag in people with Hepatitis C, Chronic, run by GlaxoSmithKline at 191 sites in 25 countries.

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 assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
eltrombopag
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
687 participants
Where
191 sitesin 25 countries
Study dates
Oct 2007to May 2011
Phase
Phase 3
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

  • Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned

Who cannot join

  • Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin
  • Subjects with a history of any one of the following:
  • Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder
  • The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional:
  • Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago
  • Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, antithrombin III (ATIII) deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months prior to the first dose of eltrombopag Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit

Trial locations and contacts

191 sites in 25 countries.

191 sites in 25 countries

United States47 sites

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Baltimore, Maryland, 21202

  • GSK Investigational Site

    Birmingham, Alabama, 35294-0005

  • GSK Investigational Site

    Bradenton, Florida, 34209

  • GSK Investigational Site

    Burlington, Massachusetts, 01805

  • GSK Investigational Site

    Charlottesville, Virginia, 22908

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Durham, North Carolina, 27705

  • GSK Investigational Site

    Fairfax, Virginia, 22031

  • GSK Investigational Site

    Gainsville, Florida, 32610

  • GSK Investigational Site

    Galveston, Texas, 77555-0435

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033-0850

  • GSK Investigational Site

    Honolulu, Hawaii, 96817

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jackson, Tennessee, 38301

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Little Rock, Arkansas, 72205-7199

  • GSK Investigational Site

    Los Angeles, California, 90017

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Manhasset, New York, 11030

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Nashville, Tennessee, 37205

  • GSK Investigational Site

    Nashville, Tennessee, 37212

  • GSK Investigational Site

    New Haven, Connecticut, 06520

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Portland, Oregon, 97239

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Rochester, New York, 14642

  • GSK Investigational Site

    San Antonio, Texas, 78215

  • GSK Investigational Site

    San Clemente, California, 92673

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    The Bronx, New York, 10468

  • GSK Investigational Site

    Tucson, Arizona, 85750

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    Valhalla, New York, 10595

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20307

  • GSK Investigational Site

    Worcester, Massachusetts, 01655

Other trials in United States

Germany33 sites

  • GSK Investigational Site

    Aachen, North Rhine-Westphalia, 52074

  • GSK Investigational Site

    Beeskow, Brandenburg, 15848

  • GSK Investigational Site

    Berlin, State of Berlin, 12203

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44787

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Deggendorf, Bavaria, 94469

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44263

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Göttingen, Lower Saxony, 37075

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44623

  • GSK Investigational Site

    Hof/Saale, Bavaria, 95028

  • GSK Investigational Site

    Kassel, Hesse, 34127

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04129

  • GSK Investigational Site

    Leverkusen, North Rhine-Westphalia, 51375

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39120

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Munich, Bavaria, 81377

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48143

  • GSK Investigational Site

    Regensburg, Bavaria, 93053

  • GSK Investigational Site

    Siegen, North Rhine-Westphalia, 57072

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70197

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

  • GSK Investigational Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Canada14 sites

  • GSK Investigational Site

    Barrie, Ontario, L4M 7G1

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    Hamilton, Ontario, L8N 4A6

  • GSK Investigational Site

    Montreal, Quebec, H2X 2P4

  • GSK Investigational Site

    Montreal, Quebec, H2X 3J4

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Ottawa, Ontario, K1N 6N5

  • GSK Investigational Site

    Toronto, Ontario, M5G 1X5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4

  • GSK Investigational Site

    Toronto, Ontario, M5T 2S8

  • GSK Investigational Site

    Toronto, Ontario, M6H 3M1

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3P9

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Italy11 sites

  • GSK Investigational Site

    Avellino, Campania, 83100

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40138

  • GSK Investigational Site

    Brescia, Lombardy, 25123

  • GSK Investigational Site

    Catanzaro, Calabria, 88100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Milan, Lombardy, 20157

  • GSK Investigational Site

    Palermo, Sicily, 90127

  • GSK Investigational Site

    Rome, Lazio, 00133

  • GSK Investigational Site

    San Giovanni Rotondo (FG), Apulia, 71013

Other trials in Italy

Spain11 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Granada, 18012

  • GSK Investigational Site

    L'Hospitalet de Llobregat. Barcelona, 08907

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28029

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

France9 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Dijon, 21019

  • GSK Investigational Site

    Marseille, 13385

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nice, 06202

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Toulouse, 31300

Other trials in France

Australia7 sites

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Melbourne, Victoria, 3168

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

Israel5 sites

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Safed, 13110

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Poland5 sites

  • GSK Investigational Site

    Bydgoszcz, 85-030

  • GSK Investigational Site

    Chorzów, 41-500

  • GSK Investigational Site

    Kielce, 25-317

  • GSK Investigational Site

    Szczecin, 71-455

  • GSK Investigational Site

    Wroclaw, 51-149

Other trials in Poland

Thailand5 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10700

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Khon Kaen, 40002

  • GSK Investigational Site

    Songkhla, 90110

Other trials in Thailand

Belgium4 sites

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

Other trials in Belgium

Russia4 sites

  • GSK Investigational Site

    Moscow, 110020

  • GSK Investigational Site

    Moscow, 129110

  • GSK Investigational Site

    Mosocow, 117593

  • GSK Investigational Site

    Smolensk, 214018

Other trials in Russia

Slovakia4 sites

  • GSK Investigational Site

    Bratislava, 811 07

  • GSK Investigational Site

    Bratislava, 833 05

  • GSK Investigational Site

    Košice, 041 66

  • GSK Investigational Site

    Martin, 036 59

Other trials in Slovakia

Taiwan4 sites

  • GSK Investigational Site

    Kaohsiung City, 80708

  • GSK Investigational Site

    Taichung, 407

  • GSK Investigational Site

    Tainan, 704

  • GSK Investigational Site

    Taipei, 100

Other trials in Taiwan

Ukraine4 sites

  • GSK Investigational Site

    Donetsk, 83114

  • GSK Investigational Site

    Kyiv, 01030

  • GSK Investigational Site

    Kyiv, 04112

  • GSK Investigational Site

    Vinnytsia, 21021

Other trials in Ukraine

United Kingdom4 sites

  • GSK Investigational Site

    Glasgow, Lanarkshire, G12 0YN

  • GSK Investigational Site

    London, NW3 2QG

  • GSK Investigational Site

    London, W2 1NY

  • GSK Investigational Site

    Plymouth, PL6 8DH

Other trials in United Kingdom

India3 sites

  • GSK Investigational Site

    Bangalore

  • GSK Investigational Site

    Chennai, 600 096

  • GSK Investigational Site

    Mumbai, 400036

Other trials in India

Netherlands3 sites

  • GSK Investigational Site

    Amsterdam, 1081 HV

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Rotterdam, 3015 CE

Other trials in Netherlands

South Korea3 sites

  • GSK Investigational Site

    Busan, 614-735

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Seoul, 135-710

Other trials in South Korea

Brazil2 sites

  • GSK Investigational Site

    Campinas, São Paulo, 13083-888

  • GSK Investigational Site

    São Paulo, São Paulo, 04023900

Other trials in Brazil

Czechia2 sites

  • GSK Investigational Site

    Prague, 140 21

  • GSK Investigational Site

    Prague, 169 02

Other trials in Czechia

Pakistan2 sites

  • GSK Investigational Site

    Lahore, 54000

  • GSK Investigational Site

    Lahore, 54600

Other trials in Pakistan

Puerto Rico2 sites

  • GSK Investigational Site

    Ponce, Puerto Rico, 00717

  • GSK Investigational Site

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

Romania2 sites

  • GSK Investigational Site

    Bucharest, 021105

  • GSK Investigational Site

    Constanța, 900708

Other trials in Romania

Hong Kong1 site

  • GSK Investigational Site

    Pokfulam

Other trials in Hong Kong

About this study

Official title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

Being tested
eltrombopag, placebo
Keywords
thrombopoietin, hepatitis C, ribavirin, platelets, Hepatitis C-related thrombocytopenia, peginterferon alfa-2a
Medical subject headings
Hepatitis C, Chronic, Jacobs syndrome, Hepatitis C

What participants receive

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

  • eltrombopagDrug

    25, 50, 75, 100 mg tablets taken once daily orally

  • placeboDrug

    matched placebo taken once daily orally

What is being measured

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

  1. Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase

    Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Secondary outcomes (22)

  1. Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase

    Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.

    Measured: From Baseline up to Week 9 in the OL Phase

  2. Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase

    In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.

    Measured: From Baseline up to Week 9 in the OL Phase

  3. Median Platelet Count at the Indicated Time Points During the OL Phase

    Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

    Measured: OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)

  4. Median Platelet Count at the Indicated Time Points During the DB Phase

    Blood taken from peripheral blood vessels was used for the measurement of platelet counts.

    Measured: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

  5. Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase

    The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  6. Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase

    RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.

    Measured: From Baseline up to Week 12

  7. Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase

    EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.

    Measured: From Baseline up to Week 12

  8. Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase

    ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.

    Measured: From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)

  9. Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase

    Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  10. Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase

    Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  11. Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase

    The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  12. Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase

    The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  13. Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase

    There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  14. Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase

    Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  15. Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase

    Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  16. Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase

    Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.

    Measured: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

  17. Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase

    Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

    Measured: DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

  18. Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase

    Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.

    Measured: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

  19. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase

    Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

    Measured: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

  20. Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase

    Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

    Measured: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

  21. Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase

    The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

    Measured: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

  22. Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase

    The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

    Measured: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Timeline

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

  1. First posted15 Aug 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionApr 2011
  4. Study completionMay 2011

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00516321
Sponsor's protocol ID
TPL103922
Status last verified
Aug 2012
First submitted
13 Aug 2007
Last updated
5 Nov 2013
Data monitoring committee
No

Publications

  • Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

    PubMed 26173631

  • Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gomez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

    PubMed 25777337

  • Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

    PubMed 24126097

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing eltrombopag in people with Hepatitis C, Chronic, run by GlaxoSmithKline at 191 sites in 25 countries.

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 1 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 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Germany, Canada, Italy, Spain and 20 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Jul 2012). 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?

Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase (time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)). 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 NCT00516321, which also lists 3 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 5 Nov 2013.

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