| Rank |
Status |
Study |
| 1 |
Unknown †
|
Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients
| Condition: |
Hepatitis C |
| Intervention: |
Drug: ribavirin pre-treatment |
| Outcome Measures: |
HCV-RNA level, Transaminases level; liver biopsy and Transient elastography at baseline and after six month since therapy conclusion |
|
| 2 |
Recruiting
|
Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)
| Condition: |
Hepatitis C |
| Interventions: |
Drug: A: Peg-interferon alpha-2a & Ribavirin; Drug: B: Peg-interferon alpha-2a & Ribavirin; Drug: C: Peg-interferon alpha-2a & Ribavirin; Drug: D: Peg-interferon alpha-2a & Ribavirin; Drug: E: Peg-interferon alpha-2a & Ribavirin; Drug: F: Peg-interferon alpha-2a & Ribavirin |
| Outcome Measures: |
Efficacy; Safety |
|
| 3 |
Recruiting
|
In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia
| Condition: |
Hepatitis C |
| Interventions: |
Drug: Pegylated interferon alpha; Drug: Ribavirin |
| Outcome Measures: |
Hepcidin levels; iron metabolism markers; heamolysis markers; inosine triphosphatase genetic variants; erythropoiesis markers |
|
| 4 |
Unknown †
|
RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin
| Condition: |
Chronic Hepatitis C |
| Interventions: |
Drug: Peg-interferon alpha 2a and ribavin; Drug: ribavirin with adaptation dose |
| Outcome Measures: |
Inter-group comparison of sustained virological response rates as defined by the proportion of subjects with a negative PCR HCV-RNA test at Week 72; Efficacy endpoints; safety endpoints; Economic endpoints |
|
| 5 |
Recruiting
|
Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)
| Conditions: |
Head and Neck Cancer; Squamous Cell Cancer |
| Intervention: |
Drug: Afatinib, Ribavirin, and weekly carboplatin/paclitaxel |
| Outcome Measures: |
maximum tolerated dose (For Dose Escalation Portion of the study); expression of PTPN13 (For Expansion Cohort only); safety and tolerability (toxicity); objective response rate; pharmacokinetics |
|
| 6 |
Recruiting
|
Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)
| Condition: |
Hepatitis C Virus Genotype 4 Infection |
| Interventions: |
Drug: Asunaprevir; Drug: Daclatasvir; Drug: Ribavirin; Drug: Pegylated Interferon alpha-2a |
| Outcome Measures: |
SVR12 Rate; Number of patients with adverse events; Treatment discontinuations; Self-reported symptoms; Patients' adherence; SVR 24 rate; HCV viral load; Number of patients with virological failure under treatment; HCV subtypic distribution; Proportion of patients with resistance mutations to Asunaprevir and/or Daclatasvir in case of virological failure; Cirrhosis evaluation; Insulin resistance : HOMA-IR score; Metabolic syndrome parameters; Liver fibrosis; Polymorphism of the gene of IL28B |
|
| 7 |
Recruiting
|
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
| Condition: |
Hepatitis C |
| Interventions: |
Biological: Pegylated Interferon Lambda; Drug: Ribasphere; Drug: Daclatasvir |
| Outcome Measures: |
Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected; Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected; Proportion of non-cirrhotic HCV GT-1b subjects with treatment-emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3, and/or thrombocytopenia as defined by platelets < 50,000 mm3) on treatment; Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or chills or pain); Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain); Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected; Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks); Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks); Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks); Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks); Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks); Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks); Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks); Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks) |
|
| 8 |
Recruiting
|
Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)
| Conditions: |
Chronic Hepatitis C; Menopause |
| Intervention: |
Drug: Pegylated Interferon, Ribavirin, Boceprevir |
| Outcome Measures: |
Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women.; Early virological response |
|
| 9 |
Recruiting
|
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
| Condition: |
Hepatitis C, Chronic |
| Interventions: |
Drug: Miravirsen; Drug: Telaprevir; Drug: Ribavirin |
| Outcome Measures: |
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.; The proportion of subjects with undetectable HCV RNA levels at end of treatment.; The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.; Change in HCV RNA levels from baseline throughout the study.; The proportion of subjects who experience virological failure throughout the study. |
|
| 10 |
Not yet recruiting
|
A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
| Conditions: |
Chronic Hepatitis C; End Stage Renal Disease |
| Interventions: |
Drug: Ribavirin; Drug: Peginterferon; Drug: Boceprevir |
| Outcome Measures: |
Percentage of patients who achieve eRVR at treatment week 28; Tolerability of treatment |
|
| 11 |
Recruiting
|
Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection
| Condition: |
Hepatitis C Virus |
| Intervention: |
Drug: ribavirin |
| Outcome Measures: |
ribavirin AUC-12 variability; safety - absolute hemoglobin declines; efficacy - early and sustained virologic response |
|
| 12 |
Unknown †
|
Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment
| Condition: |
Hepatitis C |
| Interventions: |
Other: Ribavrin; Drug: Abacavir plus Ribavirin |
| Outcome Measures: |
To evaluate the effect of abacavir (ABC) on Ribavirin Triphosphate (RBV-TP) intracellular concentrations.; To evaluate the effect of ABC on plasma RBV trough concentrations. |
|
| 13 |
Unknown †
|
Four Arms, Multicenter Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C
| Condition: |
Chronic Hepatitis C |
| Interventions: |
Drug: pegylated interferon alpha 2a and plus ribavirin; Drug: Pegylated interferon alfa-2a and ribavirin; Drug: pegylated interferon alpha 2a and ribavirin |
| Outcome Measures: |
Efficacy - Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period; Safety - adverse event rate and profile |
|
| 14 |
Recruiting
|
A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus
| Condition: |
Chronic Hepatitis C |
| Interventions: |
Drug: TMC647055; Drug: TMC435; Drug: Ritonavir; Drug: Ribavirin; Drug: Pegylated interferon alpha-2a (PegIFN); Drug: GSK2336805 |
| Outcome Measures: |
Number of patients with a sustained virologic response (SVR) 12 Weeks after the actual end of treatment; Number of patients with adverse events; Number of patients with a sustained virological response (SVR at 4 and/or 24 Weeks after the actual end of treatment); HCV RNA levels over time; Number of patients with undetectable hepatitis C virus (HCV) RNA (less than 25 IU/mL undetectable) and/or HCV RNA levels less than 25 IU/mL at all time points; Number of patients with on-treatment virologic failure; Number of patients with viral relapse; Number of patients with presence of HCV variants associated with reduced susceptibility to investigational treatment; Maximum plasma analyte concentration of TMC435; Minimum plasma analyte concentration of TMC435; Area under the plasma concentration-time curve of TMC435; Maximum plasma analyte concentration of TMC647055; Minimum plasma analyte concentration of TMC647055; Area under the plasma concentration-time curve of TMC647055; Maximum plasma analyte concentration of ritonavir (RTV); Minimum plasma analyte concentration of RTV; Area under the plasma concentration-time curve of RTV; Minimum and maximum plasma concentrations of GSK233680k; Area under the plasma concentration-time curve of GSK233680k |
|
| 15 |
Unknown †
|
Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
| Conditions: |
Chronic Hepatitis C; Neoplasms |
| Intervention: |
Drug: pegylated interferon alpha 2a and plus ribavirin |
| Outcome Measures: |
Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.; Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.; Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.; Safety - adverse event rate and profile |
|
| 16 |
Unknown †
|
Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients
| Condition: |
Malignant Solid Tumour |
| Intervention: |
Drug: Ribavirin |
| Outcome Measures: |
Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D); Phase II: Determine the overall response rate to therapy with ribavirin; Incidence and nature of DLTs; Incidence, nature and severity of adverse events; Time to and duration of response, defined as the first occurence of documented objective response until the time of recurrence or death from any cause; Clinical benefit rate, defined as the overall response rate and stable disease for greater than or equal to 24 weeks; Pharmacokinetic parameters of ribavirin determine by total exposure, maximum plasma concentration, etc.; Correlation between eIF4E activity and response; To determine the effect of ribavirin on the activity of eIF4E related pathways through correlative studies |
|
| 17 |
Unknown †
|
Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
| Condition: |
Chronic Hepatitis C |
| Interventions: |
Drug: Peg + Vitamin D + Ribavirin; Drug: Peg + Ribavirin |
| Outcome Measure: |
sustained virologic response (SVR)rate |
|
| 18 |
Recruiting
|
An Open Label Trial of Pegylated Interferon, Ribavirin and Telaprevir Versus Pegylated Interferon and Ribavirin Alone in the Treatment of Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection
| Condition: |
HIV |
| Interventions: |
Drug: Ribavirin; Drug: Telaprevir |
| Outcome Measure: |
• Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy |
|
| 19 |
Unknown †
|
Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
| Condition: |
Hemoglobinopathies |
| Intervention: |
Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin |
| Outcome Measures: |
A sustained virological response (SVR), defined as absence of HCV RNA in serum by a highly sensitive test at the end of treatment and 6 months late.; Early virological response (EVR) , defined as the loss of HCV RNA during the first 12 weeks of therapy; main side effects enclosing changes in blood transfusion requirement; increase in ferritin levels and variations in chelation treatment |
|
| 20 |
Unknown †
|
Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
| Condition: |
Chronic Hepatitis C |
| Interventions: |
Drug: ribavirin; Drug: Peginterferon alfa-2a; Drug: epoetin beta |
| Outcome Measure: |
% patients with RNA-HCV < 50 UI/ml |
|
