A Clinical Trial of KT07 Capsule in the U.S.A
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|ClinicalTrials.gov Identifier: NCT02867358|
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 31, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Drug: KT07 Capsule Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||391 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|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||July 31, 2020|
|Actual Study Completion Date :||July 31, 2020|
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 Capsule
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
- Influenza viral shedding from baseline to Day 3 and Day 6 post treatment initiation during KT07 treatment [ Time Frame: Day 1 & 3 & 6 ]Reduction in viral shedding; Influenza viral AUC
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects with acute uncomplicated influenza with oral temperature ≥ 37.8 ℃ (100.04 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.
- Subjects with RIDT confirmed influenza infection.
Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either:
- Time of the first increase in body temperature to ≥ 37.8 ℃ (100.04 °F); or
- Time when the subject experiences at least one general or respiratory symptom.
- Age 18 to 65 years old.
- Subjects who are able to understand and willing to sign the informed consent form (ICF).
- All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation.
- Subjects with severe influenza virus infection requiring inpatient treatment.
- Subjects with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the time of screening.
- Subjects who have any of the following documented conditions: uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg), diabetes, asthma (any current or recent, not childhood if resolved), COPD (any), cardiac, hepatic, renal (including eGFR<60) and hematopoietic disorders, bleeding tendency or hemorrhagic disease, neurological system disease, compromised immune system (including patients receiving immunosuppressant therapy, or those with cancer within the past 5 years or human immunodeficiency virus [HIV] infection), endocrine disorders (including thyroid disorders).
- Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
- Clinically obese subjects with BMI≥40.
- Subjects with recent history (within 1 year) of alcoholism or substance abuse.
- Received influenza vaccine within 21 days.
- Participation in other clinical trial within 1 month, or during the study.
- Pregnant or breast-feeding female subjects
- Allergy or known allergy to components of study medication.
- Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to enrollment.
- Previous history of difficulty swallowing capsules.
- Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede participation in the study or affect the study results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867358
|Study Director:||Xuedong Gao, MD||Yiling Pharmaceutical Inc.|
|Responsible Party:||Yiling Pharmaceutical Inc.|
|Other Study ID Numbers:||
|First Posted:||August 15, 2016 Key Record Dates|
|Last Update Posted:||August 31, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
acute uncomplicated influenza
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases