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To evaluate the efficacy of repeat-dose UB-621 for the recurrent genital HSV-2 infection To evaluate the safety and tolerance of repeat-dose UB-621 for the recurrent HSV-2 infection To evaluate the pharmacokinetics of repeat-dose UB-621 in RGH patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | placebo matching UB-621 |
|
| UB-621 low-dose | Experimental | low-dose of UB-621 |
|
| UB-621 high-dose | Experimental | high-dose of UB-621 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | PBO- placebo matching to UB-621 |
| |
| UB-621 low-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first recurrence | Time to first recurrence episode after experimental drug administration as reported by patient and verified by investigator. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with episodes | Proportion of subjects with episodes is calculated as the number of subjects with episodes divided by the number of total subjects. | 26 weeks |
| Lesion rate |
| Measure | Description | Time Frame |
|---|---|---|
| HSV-2 shedding rate | Viral shedding rate is defined as the number of positive anogenital swabs divided by total number of swabs. | 12 weeks |
| Clinical and Subclinical HSV-2 Shedding Rates | Daily record of subject self-assessment of genital lesions in subject diary in addition to anogenital swabs collected daily from subjects during the follow-up periods will be used to evaluate the clinical (lesional) and subclinical (non-lesional) HSV-2 shedding rates. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Shih, DVM | Contact | +886 36684800 | 3851 | linda.shih@unitedbiopharma.com |
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| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Biological |
fully human anti-HSV mAb |
|
| UB-621 high-dose | Biological | fully human anti-HSV mAb |
|
Lesion rate is calculated as the number of days with lesion divided by the number of study days.
| 26 weeks |
| Duration of recurrent lesions | Duration of recurrent lesions is calculated as consecutive days with lesions. | 26 weeks |
| Recurrence rate | Recurrence rate is defined as number of recurrences divided by the total number of study days. | 26 weeks |
| 12 weeks |
| Rate of HSV-2 Shedding Episodes | The rate of HSV-2 shedding episodes is the number of onsets of shedding episodes divided by the total number of days with swabs collected. Shedding episodes are defined as consecutive HSV-2 positive swab results including no more than 1 consecutive negative result or missed swab. The episodes are preceded and followed by 2 consecutive negative swab results. | 12 weeks |
| HSV-2 viral load | Anogenital swab samples collected from subjects during follow-up period will be used to quantify HSV-2 DNA copies. | 12 weeks |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |