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Chronic Hepatitis CPhase 4DARGEN-3NCT00830609

High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3

A Phase 4 study testing Peginterferon alfa 2 A, Peginterferon alfa 2 A, ribavirin + Epo Beta and ribavirin in people with Chronic Hepatitis C, run by Dr. Conrado Fernandez at 28 sites in Spain.

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 rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Peginterferon alfa 2 A, Peginterferon alfa 2 A, ribavirin + Epo Beta and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
28 sitesSpain
Study dates
Nov 2008to Dec 2011
Phase
Phase 4
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HCV Genotype 3
  • RNA-HCV > > 600.000 IU/ml.
  • Compromise to use contraceptive measures on treatment until 6 months after the end of treatment.

Who cannot join

  • Pregnant or breastfeeding females.
  • Concurrent treatment with antineoplastic or immunomodulatory agents, including corticosteroids or radiation therapy over the last 6 months before starting the trial
  • Treatment with investigational drugs < 6 weeks before starting the trial
  • Chronic liver disease other than hepatitis C.
  • Evidence of hepatocellular carcinoma.
  • Evidence of carcinoma hepatocellular
Show all 19Show fewer
  • Decompensated liver disease
  • Baseline Neutrophil count < 1500/cc; or Platelet count < 90,000/cc
  • Baseline Hemoglobin <12 g/dL in females o <13 g/dL in males.
  • Increased risk of anemia(Eg, thalassemia, spherocytosis..).
  • Ischemic heart disease or cerebrovascular disease.
  • Serum creatinine >1.5 times upper limit of normality.
  • History of severe psychiatric conditions (Major antidepressives or neuroleptic drugs required for major depression or psychosis), suicide attempts or psychiatric disability .
  • History of convulsive disorders.
  • Immunological conditions.
  • Chronic Obstructive Lung Disease with limited functionality
  • Severe heart disease or congestive cardiac insufficiency cardiopathy grave.
  • Advanced atherosclerosis
  • Solid organ or bone marrow transplant.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Spain28 sites

  • Hospital Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14004

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital de Getafe

    Getafe, Madrid, 28901

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18004

  • Hospital San Cecilio

    Granada, Granada

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital de León

    León, León, 24071

  • Hospital La Princesa

    Madrid, Madrid, 28006

  • Hospital Gregorio Marañon

    Madrid, Madrid, 28007

  • Hospital 12 de Octubre

    Madrid, Madrid, 28021

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Costa del Sol

    Marbella, Málaga, 29603

  • Hospital Central de Asturias

    Oviedo, Oviedo, 33006

  • Hospital Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Salamanca, 37007

  • Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital de Valme

    Seville, Sevilla, 41014

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47005

  • Hospital Santiago Apóstol

    Vitoria-Gasteiz, Vitoria, 01004

  • Hospital Clínico de Zaragoza

    Zaragoza, Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Effect of High Dose vs. Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3, High Viral Load Without Rapid Virological Response

The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.

Read the detailed description

Aims:

  1. Efficacy 1.1) Rate of RNA-HCV negative at week 4 and 24 in each arm. 1.2) Rate of SVR in each arm.
  2. Safety 2.1) Rate of adverse effects in each arm.

Design: Randomized controlled trial.

Patients will be randomly allocated into three arms:

Arm A : Peginterferon α-2a (180 μg/week)SC. plus Ribavirin (800 mg/day) p.o. over 24 weeks.

Arm B: Peginterferon α-2a (180 μg/week) plus Ribavirin (1600 mg/day) with support of Epoetin β (450 IU/kg/week) SC over 4 weeks:

B1.- If RNA-HCV undetectable at week 4, standard of care will be continued (Peginterferon α-2a, 180 μg/wee plus Ribavirin (800 mg/day) over 20 additional weeks).

B2.- If RNA-HCV were detectable at week 4, treatment will be continued with peginterferon α-2a (180 μg/week) plus RBV(1,600 mg/day) plus Epoetin β (450 UI/kg/week) over 20 additional weeks.

Sample size: 111 patients. To increase the SVR from 50% to 75%. Beta: 0.1; alfa: 0.05; Loss: 15%.

Randomization will be 1:2, 37 patients in Group A and 74 patients in group B.

Being tested
Peginterferon alfa 2 A, Peginterferon alfa 2 A, ribavirin + Epo Beta, ribavirin, Peginterferon alfa 2
Keywords
Chronic Hepatitis C, Genotype 3, High viral load
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • Peginterferon alfa 2 ADrug

    Also called Pegasys

    Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb>12 g/dL if required over 20 additional weeks (Arm B2)

  • Peginterferon alfa 2 A, ribavirin + Epo BetaDrug

    Also called Pegasys

    Ribavirin 1,600 mg/day plus peginterferon alfa 2A 180 mcg/week plus Epo beta 450 IU/Kg/day to maintain Hb>12g/dl over 4 or 24 weeks

  • ribavirinDrug

    Also called peginterferon alfa 2 a, Epoetin beta

    RBV 1600 mg/day 24 weeks

  • ribavirinDrug

    Also called Pegasys

    ribavirin 800 mg/day for 24 weeks

  • Peginterferon alfa 2Drug

    Also called Pegasys

    Peginterferon alfa 2 a 180 mcg/week for 4 weeks and then peginterferon alfa 2A for 20 weeks

  • ribavirinDrug

    Also called Pegasys

    RBV 1600 mg/day 4 weeks and then ribavirin 800 mg/day 20 weeks

Study groups in NCT00830609
Study groupRoleWhat they receive
AActive comparatorPatients in this arm will receive standard of care (Peginterferon alfa 2A 180 mcg/weeks SC plus ribavirin 800 mg/day for 24 weeks).
Receives: Drug: Peginterferon alfa 2 A; Drug: ribavirin
B1ExperimentalAfter a period of 4 weeks with peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day (Induction phase), these patients will be allocated according to negativity or positivity of RNA-HCV at week 4. If RNA-HCV negative, treatment with peginterferon alfa 2 a 180 mcg/week plus RBV 800 mg/day (SOC) will be continued over 20 additional weeks (Arm B1). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin > 12g/dL.
Receives: Drug: Peginterferon alfa 2 A; Drug: Peginterferon alfa 2 A, ribavirin + Epo Beta; Drug: Peginterferon alfa 2; Drug: ribavirin
B2ExperimentalIf RNA-HCV at week 4 remains positive after the induction phase, then peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day will be continued for 20 additional weeks (Arm B2). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin > 12g/dL.
Receives: Drug: Peginterferon alfa 2 A; Drug: Peginterferon alfa 2 A, ribavirin + Epo Beta; Drug: ribavirin

What is being measured

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

  1. Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment.

    Measured: 1 year

Secondary outcomes (1)

  1. Rate of patients with undetectable RNA-HCV in each arm at week 4 and 24 of treatment. Rate of adverse effects in each arm.

    Measured: 1 year

Timeline

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

  1. First posted28 Jan 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionSep 2011
  4. Study completionDec 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00830609
Sponsor's protocol ID
ROCHE FARMA S.A.
Acronym
DARGEN-3
Status last verified
Mar 2012
First submitted
27 Jan 2009
Last updated
13 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Fernandez-Rodriguez CM, Morillas RM, Masnou H, Navarro JM, Barcena R, Gonzalez JM, Martin-Martin L, Poyato A, Miquel-Planas M, Jorquera F, Casanovas T, Salmeron J, Calleja JL, Sola R, Alonso S, Planas R, Romero-Gomez M. Randomized clinical trial comparing high versus standard dose of ribavirin plus peginterferon alfa-2a in hepatitis C genotype 3 and high viral load. Dargen-3 study. Gastroenterol Hepatol. 2014 Jan;37(1):1-8. doi: 10.1016/j.gastrohep.2013.10.005. Epub 2013 Dec 17.

    PubMed 24360571

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa 2 A, Peginterferon alfa 2 A, ribavirin + Epo Beta and ribavirin in people with Chronic Hepatitis C, run by Dr. Conrado Fernandez at 28 sites in Spain.

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 3 inclusion and 19 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 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain. 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?

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?

Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment. (time frame: 1 year). 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 NCT00830609, 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 13 Mar 2012.

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