A Clinical Trial of KT07 Capsule in the U.S.A
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|ClinicalTrials.gov Identifier: NCT02867358|
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Drug: KT07 Capsule Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||October 2018|
Active Comparator: High dose of KT07 capsule
It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen Capsule
Active Comparator: Low dose of KT07 capsule
It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen CapsuleOther: Placebo
Placebo Comparator: Placebo
It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.
- To investigate the improvement in reducing the duration of illness compared to placebo. [ Time Frame: Up to 19 days ]
Duration of illness is defined as: the length of time to alleviation of all symptoms.
The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated.
- The reduction in duration of alleviation of individual symptom [ Time Frame: Up to 19 days ]From time zero to the time at which the symptom is less than or equal to mild and stable for at least 24 hours
- Quality of life assessment [ Time Frame: Up to 19 days ]Based on the self-assessment questionnaire
- Duration of viral shedding [ Time Frame: At day 3 and day 6 ]Use RT-PCR and TCID50 assay to quantitate virus load
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867358
|Contact: Nan Zhang, PhDfirstname.lastname@example.org|
Show 38 Study Locations
|Study Chair:||Xuedong Gao, MD||Yiling Pharmaceutical Inc.|