Please assess the completion status of the following clinical trial:

Trial Title: Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2/PHASE3
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria~Inclusion Criteria for Part A~Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.~1. Willing and able to provide written informed consent.~2. Male or female, age ≥ 18 years.~3. HCV RNA ≥ 104 IU/mL at screening.~4. Confirmed chronic HCV infection as documented by either:~   a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or~5. HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation.~6. The subject's medical records must be sufficient to categorize prior treatment history as one of the following:~   i) IFN-intolerant: subject had documented intolerance to IFN during prior IFN therapy of up to 12 weeks duration ii) Non-response: subject did not achieve undetectable HCV RNA levels on treatment iii) Relapse/Breakthrough: subject achieved undetectable HCV RNA levels during treatment or within 4 weeks after treatment and later showed detectable HCV RNA~   An Absence of cirrhosis is defined as any one of the following:~  * Liver biopsy within 2 years of Screening showing absence of cirrhosis~  * Fibroscan with a result of ≤ 12.5 kPa within 6 months of Baseline/Day1~  * FibroTest score of ≤ 0.48 AND APRI of ≤ 1 performed during Screening In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or Fibro Test.~7. Body mass index (BMI) ≥ 18 kg/m2.~8. Screening ECG without clinically significant abnormalities.~9. Subjects must have the following laboratory parameters at screening:~   * ALT ≤ 10 x the upper limit of normal (ULN)~  * AST ≤ 10 x ULN~  * Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects~  * Platelets \> 50,000 cells/mm3~  * INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR~  * Albumin ≥ 3 g/dL~  * Direct bilirubin ≤ 1.5 x ULN~  * HbA1c ≤ 10%~  * Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation~10. Subject has not been treated with any investigational drug or device within 30 days of the screening visit.~11. A female subject is eligible to enter the study if it is confirmed that she is:~    1. Not pregnant or nursing~   2. Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women \> 50 years of age with cessation \[for 12 months\] of previously occurring menses), or~   3. Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 6 months after last dose of RBV:~       * Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.~    Or~   * Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 6 months after the last dose of RBV. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone-containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.~   * Intrauterine device (IUD) with a failure rate of \< 1% per year~   * Female barrier method: cervical cap or diaphragm with spermicidal agent~   * Tubal sterilization~   * Vasectomy in male partner~12. All male study participants must agree to consistently and correctly use a condom, while their female partner agrees to use either 1 of the non-hormonal methods of birth control listed above or a hormone-containing contraceptive listed below, from the date of screening until 7 months after their last dose of RBV:~    * Implants of levonorgestrel~   * Injectable progesterone~   * Oral contraceptives (either combined or progesterone only)~   * Contraceptive vaginal ring~   * Transdermal contraceptive patch~13. Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.~14. Subject must be of generally good health as determined by the Investigator.~15. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.~Inclusion Criteria for Part B~Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.~1. Willing and able to provide written informed consent.~2. Male or female, age ≥ 18 years.~3. HCV genotype 4 at screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation. Historical result from prior participation in this study is acceptable, if applicable.~4. Cohort 1 only: HCV RNA ≥ 104 IU/mL at screening.~5. Chronic HCV infection (≥ 6 months) documented by medical history.~6. Cohort 1 only: HCV treatment naïve, defined as no prior exposure to any IFN, RBV, or other approved or experimental HCV specific direct acting antiviral agent~7. BMI ≥ 18 kg/m2~   Absence of cirrhosis is defined as any one of the following:~  1. Liver biopsy within 2 years of Screening showing absence of cirrhosis~  2. Fibroscan with a result of ≤ 12.5 kPa within 6 months of Baseline/Day1 C- Fibro Test score of ≤ 0.48 AND APRI of ≤ 1 performed during Screening~   In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or Fibro Test.~8. Screening ECG without clinically significant abnormalities.~9. Subjects must have the following laboratory parameters at screening:~   * ALT ≤ 10 x the upper limit of normal (ULN)~  * AST ≤ 10 x ULN~  * Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects~  * Platelets \> 50,000 cells/mm3~  * INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR~  * Albumin ≥ 3 g/dL~  * Direct bilirubin ≤ 1.5 x ULN~  * HbA1c ≤ 10%~  * Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation~   Subjects who received prior treatment in this study and who currently do not fulfill all of the above requirements may be enrolled in Part B Cohort 2 at the request of the Investigator and with the approval of the Medical Monitor or Study Director.~10. Subject has not been treated with any investigational drug or device within 28 days of the Baseline/Day 1 visit.~11. A female subject is eligible to enter the study if it is confirmed that she is:~    D Not pregnant or nursing e Of non-childbearing potential (ie, women who have had a hysterectomy, both ovaries removed or medically documented ovarian failure, or are postmenopausal women \> 50 years of age with cessation \[for 12 months\] of previously occurring menses), or~    F Of childbearing potential (ie, women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure). Women ≤ 50 years of age with amenorrhea will be considered to be of childbearing potential. These women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 1 until 30 days after the last dose of LDV/SOF or 6 months after last dose of RBV:~    • Complete abstinence from intercourse. Periodic abstinence from intercourse (eg, calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.~    Or~   * Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from the date of screening until 30 days after the last dose of LDV/SOF or 6 months after the last dose of RBV.~   * Intrauterine device (IUD) with a failure rate of \< 1% per year~   * Female barrier method: cervical cap or diaphragm with spermicidal agent~   * Tubal sterilization~   * Vasectomy in male partner~   * Implants of levonorgestrel~   * Injectable progesterone~   * Oral contraceptives (either combined or progesterone only)~   * Contraceptive vaginal ring~   * Transdermal contraceptive patch~12. All male study participants must agree to consistently and correctly use a condom from Baseline until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV. If their female partner is of childbearing potential (as defined above), she must use 1 of the methods of birth control listed above from the date of screening until 90 days after their last dose of LDV/SOF or 7 months after their last dose of RBV.~13. Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV or 90 days after their last dose of LDV/SOF, as applicable.~14. Subject must be of generally good health as determined by the Investigator.~15. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.~Exclusion Criteria~Exclusion Criteria for Part A~Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.~1. for treatment naïve subjects only: Prior exposure to IFN, RBV, or other approved or experimental direct-acting antiviral targeting the HCV.~2. for treatment-experienced subjects: prior exposure to a NS5a inhibitor, NS5b nucleotide inhibitor, or NS5b non-nucleotide inhibitor targeting the HCV~3. Pregnant or nursing female or male with pregnant female partner.~4. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis).~5. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).~6. Contraindication to RBV therapy e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).~7. History of malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible.~8. Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent \> 10 mg/day).~9. Clinically-relevant drug or alcohol abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription should be approved by the investigator.~10. History of solid organ transplantation.~11. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).~12. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.~13. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.~14. History of significant pulmonary disease, significant cardiac disease or porphyria.~15. Excessive alcohol ingestion, defined as 3 glasses/day (1 glass is equivalent to 284 mL beer, 125 mL wine, or 25 mL distilled spirits) for females and 4 glasses/day for males.~16. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.~17. Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1.~18. Known hypersensitivity to RBV, the study investigational medicinal product, the metabolites, or formulation excipients.~Exclusion Criteria for Part B~Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.~1. For treatment naïve subjects only (Cohort 1): Prior exposure to IFN, RBV, or other approved or experimental direct-acting antiviral targeting the HCV.~2. Current or prior history of any of the following:~   A Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) B Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol, or, current evaluation for a potentially clinically significant illness (other than HCV) C Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug D Solid organ transplantation E Significant pulmonary disease, significant cardiac disease or porphyria F Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 6 months prior to Baseline/Day 1 or that has not required medication in the last 12 months may be enrolled.~   G Any malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.), or current evaluation for possible malignancy H Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy I Significant drug allergy (such as anaphylaxis or hepatotoxicity)~3. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)~4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)~5. Use of any prohibited concomitant medications~6. Contraindication to RBV therapy, including significant history of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)~7. In the judgment of the investigatory, any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with subject treatment, assessment of compliance with the protocol~8. Pregnant or nursing females or male with pregnant female partner~9. Known hypersensitivity to RBV, SOF, or formulation excipients

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- SOF + RBV (Type: ACTIVE_COMPARATOR): Sofosbuvir 400 mg once daily +RBV (1000 mg/day) for 12-24 weeks
- sof + RBV + AH (Type: EXPERIMENTAL): Single Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg for 12-24 weeks

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete