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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

21 marzo 2016 aggiornato da: Hoffmann-La Roche

Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater Than 85 kg

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

188

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • Santurce, Porto Rico, 00909
  • Stati Uniti
    • California
      • La Jolla, California, Stati Uniti, 92037-1030
      • Long Beach, California, Stati Uniti, 90822
      • San Diego, California, Stati Uniti, 92154
      • San Diego, California, Stati Uniti, 92105
    • Connecticut
      • Farmington, Connecticut, Stati Uniti, 06030
    • Florida
      • Bradenton, Florida, Stati Uniti, 34209
      • Gainesville, Florida, Stati Uniti, 32610-0214
      • Jacksonville, Florida, Stati Uniti, 32207
      • Wellington, Florida, Stati Uniti, 33414
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96817
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63104
    • New York
      • Manhasset, New York, Stati Uniti, 11030
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7584
      • Statesville, North Carolina, Stati Uniti, 28677
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45267-0595
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
    • Texas
      • Houston, Texas, Stati Uniti, 77030
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84121
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22906-0013
      • Richmond, Virginia, Stati Uniti, 23249

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • adult patients >=18 years of age;
  • body weight >85kg (187lbs);
  • CHC (genotype 1);
  • liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
  • use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

  • women who are pregnant or breastfeeding;
  • male partners of women who are pregnant;
  • conditions associated with decompensated liver disease;
  • other forms of liver disease, including liver cancer;
  • human immunodeficiency virus infection;
  • previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
Droga: ribavirin [Copegus]
600mg po bid for 48 weeks
Droga: ribavirin [Copegus]
800mg po bid for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
180 micrograms sc weekly for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
270 micrograms sc weekly for 48 weeks
Sperimentale: PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
Droga: ribavirin [Copegus]
600mg po bid for 48 weeks
Droga: ribavirin [Copegus]
800mg po bid for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
180 micrograms sc weekly for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
270 micrograms sc weekly for 48 weeks
Sperimentale: PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
Droga: ribavirin [Copegus]
600mg po bid for 48 weeks
Droga: ribavirin [Copegus]
800mg po bid for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
180 micrograms sc weekly for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
270 micrograms sc weekly for 48 weeks
Sperimentale: PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Droga: ribavirin [Copegus]
600mg po bid for 48 weeks
Droga: ribavirin [Copegus]
800mg po bid for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
180 micrograms sc weekly for 48 weeks
Droga: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
270 micrograms sc weekly for 48 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
HCV RNA Profile During The First 24 Weeks
Lasso di tempo: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
Percentage of Participants With Virological Response Over Time to Week 24
Lasso di tempo: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24
Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.
72 hours post-dose, Weeks 1, 2, 4, 12, and 24
Percentage of Participants With Predicted Sustained Virological Response
Lasso di tempo: Week 4 and 12
The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR."
Week 4 and 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Sustained Virological Response
Lasso di tempo: Week 72
SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.
Week 72
Percentage of Participants With Virological Response at the End of the Treatment Period
Lasso di tempo: Week 48
Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.
Week 48
Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
Lasso di tempo: Week 60
Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.
Week 60
Percentage of Participants With Adverse Events and Serious Adverse Events
Lasso di tempo: Up to Week 72
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Up to Week 72
Percentage of Participants With Marked Laboratory Abnormalities
Lasso di tempo: Up to Week 60
Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 - 20.0 (g/dL),platelets 100 - 700 (10^9/L), lymphocyte 1.00 - 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 - 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 - 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 - 50 (U/L), alkaline phosphatase 0 - 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 - 120 (U/L),Total protein 55 - 87 (g/L),total bilirubin 0 - 34.2 (μmol/L),BUN 0 - 14.3 (mmol/L),creatinine 0 - 154 (μmol/L),chloride 95 - 115 (mmol/L),potassium 3.0 - 6.0 (mmol/L), sodium 130 - 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 - 10.0 (mU/L),triglycerides 0.00 - 2.83 (mmol/L), calcium 2.00 - 2.90 (mmol/L),phosphate 0.75 - 1.60 (mmol/L),Blood Glucose 2.80 - 11.10 (mmol/L),Uric Acid 0 - 600 (μmol/L),proteinuria 0 - 1 (0 to 4+), glycosuria 0 - 1 (0 to 4+), hematuria 0 - 1 (0 to 4+).
Up to Week 60
Percentage of Participants With Abnormal Vital Signs
Lasso di tempo: Up to Week 72
Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.
Up to Week 72
Total BDI-II (Beck Depression Inventory) Scores
Lasso di tempo: From Baseline (Day 1) to Week 72
The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit.
From Baseline (Day 1) to Week 72

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2004

Completamento primario (Effettivo)

1 dicembre 2005

Completamento dello studio (Effettivo)

1 dicembre 2005

Date di iscrizione allo studio

Primo inviato

10 febbraio 2004

Primo inviato che soddisfa i criteri di controllo qualità

12 febbraio 2004

Primo Inserito (Stima)

13 febbraio 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 marzo 2016

Ultimo verificato

1 marzo 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NV17318

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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