Chronic Hepatitis CPhase 4PERICONCT00526448
Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
A Phase 4 study testing ribavirin, Peginterferon alfa-2a and epoetin beta in people with Chronic Hepatitis C, run by Hospital Carlos III, Madrid at 40 sites in Spain.
Trial summary
To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- ribavirin, Peginterferon alfa-2a and epoetin beta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 40 sitesSpain
- Study dates
- Jun 2007to Feb 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients > 18 years of age
- Serologic evidence of anti-HCV
- Detectable plasma HCV-RNA
- Serologic evidence of HIV-1 infection
- CD4 cell count >/= 250 cell/mm3
- Stable status of HIV-1 infection in the opinion of the investigator
Show all 10Show fewer
- Patients on stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline whose HAART regimen (drugs and dosage) is expected to remain unaltered for the first 6 weeks of this study
- Patients who have not been on HAART for at least 6 weeks prior to randomization who are willing to delay initiation of HAART therapy for at least 6 weeks
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- Willingness to give written informed consent
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Male partners of women who are pregnant
- IFN/ribavirin therapy at any previous time
- Child Pugh > 6 (Child Pugh B or C)
- History or conditions consistent with decompensated liver disease
- Any investigational drug 6 weeks prior to the first dose of study drug (expanded access programs for HIV treatment are allowed)
Show all 30Show fewer
- Patients treated with didanosine and/or zidovudine
- Positive test at anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg
- History or other evidence of a medical condition associated with chronic liver disease other than HCV
- Hepatocarcinoma observed in the liver ecography
- Serum concentrations of ceruloplasmin or alfa1-antitrypsin at screening consistent with an increased risk of metabolic liver disease
- Active HIV-related opportunistic infection and/or malignancy requiring acute systemic therapy
- Absolute neutrophil count (ANC) < 1500 cells/mm3
- Hgb < 11 g/dL in women or 12 g/dL in men or any patient for whom anemia would be medically problematic
- Hemoglobinopathy or any other cause of or tendency for hemolysis
- Platelet count < 50,000 cells/mm3
- History of G-CSF, GM-CSF or epo treatment during 3 months prior to the first dose of study drug
- Serum creatinine level > 1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of significant cardiac disease that could be worsened by acute anemia
- History of thyroid disease poorly controlled on prescribed medications
- Evidence of severe retinopathy
- History of major organ transplantation with an existing functional graft
- History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of any systemic anti-neoplastic or immunomodulatory treatment 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
- Concomitant medication with rifampin/rifampicin, rifabutin, pyrazinamide, isoniazid, gancyclovir, thalidomide, oxymetholone, immunomodulatory treatments and systemic antiviral agents as adjuvant therapy for CHC
- Drug use within 6 months of 1st dose and excessive alcohol consumption
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Spain40 sites, 40 recruiting
- Not yet recruiting
Hospital Juan Canalejo
A Coruña, A Coruña, 15006
Angeles Castro, Dr., miriamca@udc.es
Jose Domingo Pedreira, Dr., MInternaB@canalejo.org
- Not yet recruiting
Hospital de Albacete
Albacete, Albacete, 02006
Elisa Martínez Alfaro, Dr., +34967 597 253, emartineza@ono.es
Elisa Martínez Alfaro, Dr.
- Not yet recruiting
Hospital de Alcorcon
Alcorcón, Madrid, 28922
Juan Emilio Losa, Dr., +3491 6219400, jelosa@fhalcorcon.es
Juan Emilio Losa, Dr.
- Recruiting
Hospital de Cruces
Barakaldo, Vizcaya, 48913
Koldo Aguirrebengoa, Dr, +34946006379, kaguirrebengoa@hcru.osakidetza.net
Koldo Aguirrebengoa, Dr
- Recruiting
Hospital Santa Creu y Sant Pau
Barcelona, Barcelona, 08025
Josep Cadafalch, Dr., +3493 556 56 24, jcadafalch@hsp.santpau.es
Josep Maria Guardiola, Dr., +3493 556 56 24, jguardiola@hsp.santpau.es
- Not yet recruiting
Hospital General de Elche
Elche, Alicante, 03203
Clara Maria Escolano, Dr., +34966 679 154, cescolanoh@coma.es
Clara Maria Escolano, Dr.
- Not yet recruiting
Hospital Arquitecto Marcide
Ferrol, La Coruña, 15405
Ana Mariño, Dr, +34981334000, ana.marino.callejo@sergas.es
Ana Mariño, Dr
- Not yet recruiting
Hospital Clínico san Cecilio
Granada, Granada, 18012
Jose Hernandez Quero, Dr., +34958 249 079, jhquero@ugr.es
José Hernandez Quero, Dr.
- Not yet recruiting
Hospital San Jorge
Huesca, Huesca, 22004
Miguel Angel Berdú, Dr, +34974247000, med001689@saludalia.com
Miguel Angel Berdú, Dr
- Not yet recruiting
Hospital General de Jerez de la Frontera
Jerez de la Frontera, Cadiz, 11407
Alberto Terrón, +34 956 032 062, jaterron@hotmail.com
Alberto Terrón, Dr.
- Not yet recruiting
Hospital General de la Palma
la palma, Santa Cruz de Tenerife, 38713
Vicente Pueyo, Dr., +34922185372, vpueyo@hotmail.com
Vicente Pueyo, Dr.
- Not yet recruiting
Hospital Doctor Negrín
Las Palmas de Gran Canarias, Gran Canaria, 35020
Rafael Granados, Dr., +34928 450 683, rafagramon@wanadoo.es
Miguel Angel Cardenas, Dr., mcarsa2@hotmail.com
- Not yet recruiting
Hospital Severo Ochoa
Leganés, Madrid, 28911
Rafael Rodriguez-Rosado, Dr., rafael.rrosado@gmail.com
Rafael Rodriguez-Rosado, Dr.
- Not yet recruiting
Hospital Xeral-Caldé
Lugo, Lugo, 27004
Juan Carlos Corredoira, Dr., +34982 29 62 60, juan.corredoira.sanchez@sergas.es
Maria José Lopez, Dr., +34982 29 62 60, mariajose.lopez.alvarez@sergas.es
- Not yet recruiting
Hospital de la Princesa
Madrid, Madrid, 28006
Ignacio Santos, Dr., +3491 5202236, isantosg@hotmail.com
Ignacio Santos, Dr.
- Not yet recruiting
Hospital Gregorio Marañón
Madrid, Madrid, 28007
Pilar Miralles, Dr., pmiralles.hgugm@salud.madrid.org
Pilar Miralles, Dr.
- Recruiting
Hospital Carlos III
Madrid, Madrid, 28029
Vicente Soriano, Dr, +34914532500, vsoriano@dragonet.es
Pablo Barreiro, Dr, +34914532500, pbarreiro@v4066.drago.net
- Not yet recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Maria Jesús Téllez, Dr., +3491 3303538, mjtellezm@hotmail.com
Maria Jesús Téllez, Dr.
- Not yet recruiting
Hospital 12 de Octubre
Madrid, Madrid, 28041
Rafael Rubio, Dr., +3491 390 80 28, rrubiog@saludalia.com
Rafael Rubio, Dr.
- Recruiting
Hospital Clínico Virgen de la Victoria
Málaga, Málaga, 29010
Mercedes González, Dr., +34952 649 393, med006801@saludalia.com
Mercedes Gonzalez, Dr.
- Not yet recruiting
Hospital Santa Maria del Rosell
Murcia, Murcia, 30203
Jose Adolfo Garcia Henarejos, Dr., +34968325226
Jose Adolfo Garcia Henarejos, Dr.
- Not yet recruiting
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
Victor Asensi, Dr., +34985108000, vasensia@medynet.com
Victor Asensi, Dr.
- Not yet recruiting
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07014
Lucia Bonet, Dr., +34971175000, lbonet@hsd.es
Lucia Bonet, Dr.
- Not yet recruiting
Hospital General de Fuerteventura
Puerto del Rosario, Fuerteventura, 35600
Jesús Flores, Dr., jfmagad@terra.es
Jesús Flores, Dr.
- Not yet recruiting
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Manuel Cervantes, Dr., +34937231010, mcervantes@cspt.es
Manuel Cervantes, Dr.
- Not yet recruiting
Hospital Clínico de Salamanca
Salamanca, Salamanca, 37007
Alicia Iglesias, Gómez, +34923291100, a_iglesias74@yahoo.es
Miguel Cordero, Dr., +34923291100, magnus@usal.es
- Not yet recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Remedios Alemán, Dr., +34922678000, mraleman@comtf.es
Juan Luis Gómez, Dr., +34922678000, infecciones@huc.canarias.org
- Not yet recruiting
Hospital de la Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
Marcelino Hayek, Dr., +34922 60 20 21, ihayper@gobiernodecanarias.org
Marcelino Hayek, Dr.
- Not yet recruiting
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Santiago Echevarria, Dr., +34942202669, mirevs@humv.es
Carmen Fariña, Dr., +34942203375, mirfac@humv.es
- Not yet recruiting
Hospital Clínico Universitario
Santiago, La Coruña, 15706
Elena Losada, Dr, +34981195266, elena.losada.arias@sergas.es
Arturo Prieto, Dr, +34981195266, arturo.prieto.martinez@sergas.es
- Not yet recruiting
Hospital Virgen de la Macarena
Seville, Sevilla, 41009
Maria José Rios, Dr., +34955 008 520, MJRIOSVILLEGAS@terra.es
Maria José Rios, Dr.
- Not yet recruiting
Hospital de Valme
Seville, Sevilla, 41014
Juan Antonio Pineda, Dr., +34955 015 887, japineda@telefonica.net
Juan Antonio Pineda, Dr.
- Not yet recruiting
Hospital Universitario la Fé
Valencia, Valencia, 46009
José La Cruz, Dr., +3496 386 27 00 ext. 40352, lacruz_jos@gva.es
José La Cruz, Dr.
- Not yet recruiting
Hospial Clinico Universitario de Valencia
Valencia, Valencia, 46010
Maria José Galindo, Dr., +34963862600, pepagal@hotmail.com
Maria José Galindo, Dr.
- Not yet recruiting
Hospital Clínico de Valladolid
Valladolid, Valladolid, 47011
Miguel Angel del Pozo, Dr., +34983420000 ext. 343, "mdelpozo@med.uva.es mdelpozo@med.uva.es
Isabel González Gilabert, Dr., +34983420000 ext. 343, isabel46@ono.com
- Recruiting
Hospital Xeral-Cíes
Vigo, Pontevedra, 36204
Celia Miralles, Dr, +34986816000 ext. 16104, maria.celia.miralles.alvarez@sergas.es
Antonio Ocampo, Dr, +34986816000 ext. 16104, aocampo@arrakis.es
- Not yet recruiting
Hospital do Meixoeiro
Vigo, Pontevedra, 36214
Luis Morano, Dr., +34986 81 11 11 ext. 11386, luis.morano.amado@sergas.es
Luis Morano, Dr.
- Not yet recruiting
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, 01009
Joseba Portu, Dr., +3494 5007000 ext. 5326, jportu@htxa.osakidetza.net
Joseba Portu, Dr.
- Not yet recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009
Isabel Sanjoaquín, Dr., +34976 556400 ext. 2664, isanjoaquin@able.es
Santiago Letona, Dr., santiagoletona@yahoo.es
- Not yet recruiting
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
Carlos Ramos, Dr., cramosp@salud.aragon.es
Carlos Ramos, Dr.
About this study
Official title: Open, Multicentre,Randomized Phase IV Trial to Evaluate Efficacy/Safety to Extend Treatment Duration With Peginterferon Alfa-2a+High Dose of Ribavirin Supporting Epo β in Treatment of CHC in HIV-HCV Patients Who Not Clear Virus at Week 4
To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight).
To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week).
Read the detailed description
The PRESCO study (ribavirin dose 1000-1200 mg/day) emphasized that optimal ribavirin exposure seems to be crucial to maximize sustained virological response and minimize the incidence of relapses after treatment discontinuations.
Recent reports showed that it is beneficial to extend the treatment duration in patients without rapid virological response at 4 weeks (RNA-HCV < 50 UI/ml).
- Conditions
- Chronic Hepatitis C
- Being tested
- ribavirin, Peginterferon alfa-2a, epoetin beta
- Keywords
- high dose of ribavirin, extend treatment duration, tailoring treatment
- 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.
ribavirinDrug
2000 mg/day
ribavirinDrug
1000-1200 mg/day
Peginterferon alfa-2aDrug
Peginterferon alfa-2a 180 mcg/week
epoetin betaDrug
epoetin beta 450 UI/week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week Receives: Drug: ribavirin; Drug: Peginterferon alfa-2a; Drug: epoetin beta |
| 2 | Active comparator | Peginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day Receives: Drug: ribavirin; Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
% patients with RNA-HCV < 50 UI/ml
Measured: 24 weeks after the end of treatment
Secondary outcomes (1)
% patients with RNA-HCV < 50 UI/ml
Measured: 4 weeks on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJun 2007
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Carlos III, Madrid
- Sponsor type
- University, hospital or other
- Investigators
- Vicente Soriano, Dr, Study chair, Hospital Carlos III. Madrid. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526448
- Sponsor's protocol ID
- 2006-005940-99
- Acronym
- PERICO
- Status last verified
- Jan 2009
- First submitted
- 5 Sep 2007
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vispo E, Labarga P, Guardiola JM, Barreiro P, Miralles C, Rubio R, Miralles P, Aguirrebengoa K, Portu J, Morello J, Rodriguez-Novoa S, Soriano V; PERICO Study Group. Preemptive erythropoietin plus high ribavirin doses to increase rapid virological responses in HIV patients treated for chronic hepatitis C. AIDS Res Hum Retroviruses. 2010 Apr;26(4):419-24. doi: 10.1089/aid.2009.0120.
PubMed 20377423
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicentre,Randomized Phase IV Trial to Evaluate Efficacy/Safety to Extend Treatment Duration With Peginterferon Alfa-2a+High Dose of Ribavirin Supporting Epo β in Treatment of CHC in HIV-HCV Patients Who Not Clear Virus at Week 4
- ClinicalTrials.gov ID
- NCT00526448
- Acronym / sponsor ID
- PERICO / 2006-005940-99
- Conditions
- Chronic Hepatitis C
- Keywords
- high dose of ribavirin, extend treatment duration, tailoring treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Hospital Carlos III, MadridUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Feb 2010 (estimated)
- First posted
- 10 Sep 2007 (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.
To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight).
To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week).
Detailed description
The PRESCO study (ribavirin dose 1000-1200 mg/day) emphasized that optimal ribavirin exposure seems to be crucial to maximize sustained virological response and minimize the incidence of relapses after treatment discontinuations.
Recent reports showed that it is beneficial to extend the treatment duration in patients without rapid virological response at 4 weeks (RNA-HCV < 50 UI/ml).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ribavirin, Drug: Peginterferon alfa-2a, Drug: epoetin betaPeginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week |
| 2 | Active comparator | Drug: ribavirin, Drug: Peginterferon alfa-2aPeginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients > 18 years of age
- Serologic evidence of anti-HCV
- Detectable plasma HCV-RNA
- Serologic evidence of HIV-1 infection
- CD4 cell count >/= 250 cell/mm3
Key exclusion criteria (30 listed)
- Women with ongoing pregnancy or breast feeding
- Male partners of women who are pregnant
- IFN/ribavirin therapy at any previous time
- Child Pugh > 6 (Child Pugh B or C)
- History or conditions consistent with decompensated liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ribavirin2000 mg/day | Drug | 1 |
| ribavirin1000-1200 mg/day | Drug | 2 |
| Peginterferon alfa-2aPeginterferon alfa-2a 180 mcg/week | Drug | 1, 2 |
| epoetin betaepoetin beta 450 UI/week | Drug | 1 |
Primary outcome
% patients with RNA-HCV < 50 UI/ml
Time frame: 24 weeks after the end of treatment
1 secondary outcome
% patients with RNA-HCV < 50 UI/ml
Time frame: 4 weeks on treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Derived from this study: PubMed 20377423Vispo E, Labarga P, Guardiola JM, Barreiro P, Miralles C, Rubio R, Miralles P, Aguirrebengoa K, Portu J, Morello J, Rodriguez-Novoa S, Soriano V; PERICO Study Group. Preemptive erythropoietin plus high ribavirin doses to increase rapid virological responses in HIV patients treated for chronic hepatitis C. AIDS Res Hum Retroviruses. 2010 Apr;26(4):419-24. doi: 10.1089/aid.2009.0120.
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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.
Vicente Soriano, Dr study chair
Hospital Carlos III. Madrid. Spain
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ribavirin, Peginterferon alfa-2a and epoetin beta in people with Chronic Hepatitis C, run by Hospital Carlos III, Madrid at 40 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 10 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicente Soriano, Dr (+34914532500, vsoriano@dragonet.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% patients with RNA-HCV < 50 UI/ml (time frame: 24 weeks after the end of 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 NCT00526448, 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 29 Jan 2009.