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| ID | Type | Description | Link |
|---|---|---|---|
| VX-950-TiDP24-C210 |
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The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.
This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week). The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin | Experimental | Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 2 to 50. |
|
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Experimental | Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48. |
|
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Active Comparator | Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa 2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telaprevir | Drug | Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology. | Baseline and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral Response (Undetectable HCV RNA) | Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group. |
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Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection
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| Name | Affiliation | Role |
|---|---|---|
| Tibotec-Virco Virology BVBA Clinical Trial | Tibotec BVBA | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24886541 | Derived | De Meyer S, Ghys A, Dierynck I, Beumont M, Luo D, Picchio G. Virologic characterization of genotype 4 hepatitis C virus variants in patients treated with telaprevir. Virol J. 2014 May 16;11:93. doi: 10.1186/1743-422X-11-93. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50. |
| FG001 | Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. |
| FG002 | Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology. | Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | Median | Full Range | log 10 IU/mL | Baseline and Day 15 |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Janssen Research & Development, LLC, Titusville, NJ | 609-730-3174 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C486464 | telaprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Pegylated-interferon-alfa-2a | Drug | Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50. |
|
| Placebo | Drug | Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks. |
|
| Ribavirin | Drug | Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50. |
|
| Day 15 up to EOT (Week 48/50 or early discontinuation) |
| Median Time to First Viral Response (Undetectable HCV RNA) | Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected. | Up to Week 48/50 |
| Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group. | Day 8, Day 12, Day 15, Week 24/26 and Week 36/38 |
| Percentage of Participants With Sustained Viral Response (SVR) | Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication. | Week 12 and 24 after the last dose of study medication |
| Percentage of Participants With Relapse | Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse. | Week 24 after EOT (Week 48/50 or early discontinuation) |
| Area Under the Serum Concentration-Time Curve (AUC) | The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method. | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
| Maximum Serum Concentration (Cmax) of Telaprevir | The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
| Pre-Dose Serum Concentration (C[0h]) of Telaprevir | The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). | 0 hour (pre-dose) at Day 15 |
| Minimum Serum Concentration (Cmin) of Telaprevir on Day 15 | The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here. | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15 |
| Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir | The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test). | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
| Average Steady-State Serum Concentration (Css,av) of Telaprevir | The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
| Lost to Follow-up |
|
| Reached a virologic endpoint |
|
| Participant non-compliant |
|
| Travel |
|
| BG001 | Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. |
| BG002 | Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Median | Inter-Quartile Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | All Participants enrolled were from France. | Number | Participants |
|
Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50. |
| OG001 | Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. |
| OG002 | Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. |
|
|
| Secondary | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group. | Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | Number | Percentage of participants | Day 15 up to EOT (Week 48/50 or early discontinuation) |
|
|
|
| Secondary | Median Time to First Viral Response (Undetectable HCV RNA) | Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected. | Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. | Posted | Median | 95% Confidence Interval | Days | Up to Week 48/50 |
|
|
|
| Secondary | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group. | Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. | Posted | Number | Participants | Day 8, Day 12, Day 15, Week 24/26 and Week 36/38 |
|
|
|
| Secondary | Percentage of Participants With Sustained Viral Response (SVR) | Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication. | Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. | Posted | Number | Percentage of participants | Week 12 and 24 after the last dose of study medication |
|
|
|
| Secondary | Percentage of Participants With Relapse | Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse. | Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. "N" signifies those participants who were evaluated for this measure. | Posted | Number | Percentage of participants | Week 24 after EOT (Week 48/50 or early discontinuation) |
|
|
|
| Secondary | Area Under the Serum Concentration-Time Curve (AUC) | The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method. | Intent-to-treat (ITT) population included any randomized participant who received at least 1 dose of telaprevir/placebo. "n" signifies number of participants with data for this measure at the specified time point for each arm group respectively. | Posted | Mean | Standard Deviation | nanogram*hour/milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
|
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) of Telaprevir | The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). | ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "n" signifies number of participants with data for this measure at the specified time point for each arm group respectively. | Posted | Mean | Standard Deviation | Nanogram/milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
|
|
|
|
| Secondary | Pre-Dose Serum Concentration (C[0h]) of Telaprevir | The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). | ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "N" signifies those participants who were evaluated for this measure. | Posted | Mean | Standard Deviation | Nanogram/milliliter (ng/mL) | 0 hour (pre-dose) at Day 15 |
|
|
|
|
| Secondary | Minimum Serum Concentration (Cmin) of Telaprevir on Day 15 | The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here. | ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "N" signifies those participants who were evaluated for this measure. | Posted | Mean | Standard Deviation | Nanogram/milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15 |
|
|
|
|
| Secondary | Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir | The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test). | ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "n" signifies number of participants with data for this measure at the specified time point for each arm group respectively. | Posted | Median | Full Range | Hours | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
|
|
|
| Secondary | Average Steady-State Serum Concentration (Css,av) of Telaprevir | The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). | ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. "N" signifies those participants who were evaluated for this measure. | Posted | Mean | Standard Deviation | Nanogram/milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 |
|
|
|
| 1 |
| 8 |
| 8 |
| 8 |
| EG001 | Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. | 0 | 8 | 8 | 8 |
| EG002 | Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. | 0 | 8 | 8 | 8 |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Anal pruritus | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
The Investigator agrees that before he/she publishes any results of this trial he/she shall allow at least 45 days for the Sponsor to review the pre-publication manuscript prior to submission of the manuscript to the Publisher. In accordance with generally recognized principles of scientific collaboration, co-authorship with any company personnel will be discussed and mutually agreed upon before submission of the manuscript to the Publisher.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
|
| Week 12/14 (n=7, 8, 7) |
|
| Week 24/26 (n=6, 8, 8) |
|
| Week 36/38 (n=6, 8, 5) |
|
| Week 48/50 (n=4, 7, 5) |
|
| EOT (n=8, 8, 8) |
|
| Title | Measurements |
|---|---|
|
| Day 15 |
|
| Week 24/26 |
|
| Week 36/38 |
|
| Title | Measurements |
|---|---|
|
| Least square mean ratio |
| 1.33 |
| 90 |
| 1.03 |
| 1.72 |
Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects. |
| No |
| Superiority or Other |
| Least square mean ratio |
| 1.32 |
| 90 |
| 1.05 |
| 1.66 |
Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects. |
| No |
| Superiority or Other |