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Для 2-3 генотипов для детей исследуется комбинация софосбувир+рибавирин (даклатесвир в исследованиях не участвует!!!), вот что предлагается:
Arms Assigned Interventions
Experimental: SOF+RBV 7 days (PK Lead-in, Cohort 1)
Participants between and including the ages of 12 and 17 years old weighing ≥ 45 kg will receive SOF tablets (400 mg: 1 x 400 mg, or 4 x 100 mg) + RBV for 7 days. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (400 mg: 8 x 50mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Experimental: SOF+RBV 7 days (PK Lead-in, Cohort 2)
Following completion of study treatment in Cohort 1 and pending PK and safety results, participants between and including the ages of 6 and 11 years old weighing ≥ 17 kg and < 45 kg will receive SOF tablets (200 mg: 2 x 100 mg) + RBV for 7 days. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (200 mg: 4 x 50mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Experimental: SOF+RBV 7 days (PK Lead-in, Cohort 3)
Following completion of study treatment in Cohort 2 and pending PK and safety results, participants between and including the ages of 3 and 5 years will receive SOF based on their weight. Participants weighing ≥ 17 kg will receive 200 mg SOF (4 x 50 mg capsules containing granules) + RBV for 7 days and those weighing <17 kg will receive 150 mg SOF (3 X 50 mg capsules containing granules) + RBV for 7 days. Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Experimental: SOF+RBV 12 weeks (Genotype 2, Group 1)
During the Treatment Phase, participants between and including the ages of 12 and 17 years old with genotype 2 HCV infection will receive SOF (400 mg: 1 x 400 mg, or 4 x 100 mg) + RBV for 12 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (400 mg: 8 x 50 mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Experimental: SOF+RBV 12 weeks (Genotype 2, Group 2)
During the Treatment Phase, participants between and including the ages of 6 and 11 years old with genotype 2 HCV infection will receive SOF (200 mg: 2 x 100 mg) + RBV for 12 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (200 mg: 4 x 50 mg). Participants between and including the ages of 3 and 5 will receive SOF based based on their weight. Participants weighing ≥ 17kg will receive 200 mg SOF (4 x 50 mg capsules containing granules) + RBV for 7 days and those weighing < 17kg will receive 150 mg SOF (3 x 50 mg capsules containing granules) + RBV for 7 days. Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Experimental: SOF+RBV 24 weeks (Genotype 3, Group 1)
During the Treatment Phase, participants between and including the ages of 12 and 17 years old with genotype 3 HCV infection will receive SOF tablets (400 mg: 4 x 100 mg) + RBV for 24 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (400 mg: 8 x 50 mg). Participants will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
Drug: SOF (oral tablets)
SOF tablets administered orally once daily
Experimental: SOF+RBV 24 weeks (Genotype 3, Group 2)
During the Treatment Phase, participants between and including the ages of 6 and 11 years old with genotype 3 HCV infection will receive SOF (200 mg: 2 x 100 mg) + RBV for 24 weeks. If participants are unable to swallow SOF tablets, they will receive SOF oral granules (200 mg: 4 x 50 mg). Participants between and including the ages of 3 and 5 will receive SOF based based on their weight. Participants weighing ≥ 17kg will receive 200 mg SOF (4 x 50 mg capsules containing granules) and those weighing < 17 kg will receive 150 mg SOF .All participants between the ages of 3 and 5 will receive SOF oral granules (3 x 50 mg capsules containing granules). Participants between and including the ages of 3 and 11 years old will receive RBV up to 1400 mg per day based on weight in a divided daily dose.
https://clinicaltrials.gov/ct2/show/NCT ... ren&rank=1
Клинические исследования для детей с использованием Харвони , что предлагается на сегодня по дозам (это важно для тех кто вынужден не дожидаясь окончания клинических исследований лечить детей сегодня), успехов Вам в борьбе с циррозом и ГЦК.
Arms Assigned Interventions
Experimental: PK Lead-in Phase, Cohort 1
During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to swallow. After screening, participants between 12 to < 18 years of age weighing ≥ 45 kg will receive LDV/SOF FDC 90 mg/400 mg for 10 days (or LDV/SOF FDC 4 x 22.5 mg/100 mg based on swallowability assessment during screening).
Experimental: PK Lead-in Phase, Cohort 2
During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to swallow. After screening, participants between 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg will receive LDV/SOF FDC 2 x 22.5 mg/100 mg for 10 days.
PK Lead-in Phase, Cohort 3
Participants between 3 to < 6 years of age weighing ≥ 17 kg will receive 45 mg/ 200 mg LDV/SOF FDC and those weighing < 17 kg will receive 33.75 mg/ 150 mg LDV/SOF FDC for 10 days.
Treatment Phase, Group 1
Participants not rolling over from the PK Lead-in Phase will receive placebo to match LDV/SOF FDC to assess ability to swallow during screening. Participants between 12 to < 18 years of age will receive LDV/SOF FDC 90 mg/400 mg (or LDV/SOF FDC 4 x 22.5 mg/100 mg based on swallowability assessment during screening).
HCV Genotype 1, 4, 5, or 6 (United Kingdom/ United States/Australia/New Zealand): Treatment naive with or without cirrhosis and treatment-experienced without cirrhosis will receive LDV/SOF FDC for 12 weeks. Treatment-experienced with cirrhosis will receive LDV/SOF FDC for 24 weeks.
HCV Genotype 4, 5, or 6 (United States/Australia/New Zealand): Treatment-naïve or treatment-experienced participants with or without cirrhosis: LDV/SOF FDC for 12 weeks
HCV Genotype 3 (United Kingdom): Treatment-experienced with or without cirrhosis participants will receive LDV/SOF FDC + RBV for 24 weeks.
xperimental: Treatment Phase, Group 2
Participants not rolling over from the PK Lead-in Phase will receive placebo to match LDV/SOF FDC to assess ability to swallow during screening. Participants between 3 to < 12 years of age will receive LDV/SOF FDC (age-appropriate dose and formulation pending PK and safety results from Cohort 2 in PK lead-in phase).
HCV Genotype 1, 4, 5, or 6 (United Kingdom/ United States/Australia/New Zealand): Treatment naive with or without cirrhosis and treatment-experienced without cirrhosis will receive LDV/SOF FDC for 12 weeks. Treatment-experienced with cirrhosis will receive LDV/SOF FDC for 24 weeks.
HCV Genotype 4, 5, or 6 (United States/Australia/New Zealand): Treatment-naïve or treatment-experienced participants with or without cirrhosis: LDV/SOF FDC for 12 weeks
HCV Genotype 3 (United Kingdom): Treatment-experienced with or without cirrhosis participants will receive LDV/SOF FDC + RBV for 24 weeks.
https://clinicaltrials.gov/ct2/show/NCT ... ren&rank=3
Я не могу сказать что будет эффективнее
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